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Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results, USA
3 months ago
United States
Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, their molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution.
There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. The reliability of positive test results is not affected.
Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.
Lot Number: HB264, Use By Date: 1/1/2023, Number of Tests Shipped: 7,382
Lot Number: HY263, Use By Date: 1/1/2023, Number of Tests Shipped: 1,800
Lot Number: HY264, Use By Date: 1/1/2023, Number of Tests Shipped: 1,920
There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.
Detect is notifying all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests. The outer packaging is recyclable while all the test components can be discarded as regular trash. Detect Hubs are not affected by the recall and do not need to be discarded.
Test users who attempt to use recalled tests will be notified in the Detect App™ that the test has been recalled and may not be used.
Detect, Inc. will issue a refund* for the affected tests (as verified by Detect) upon customers’ acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.
Company name: Detect, Inc.
Brand name: Detect
Product recalled: Over the counter Covid-19 Test
Reason of the recall: There is an increased chance that the tests from the lot numbers listed below may give false negative results
FDA Recall date: December 12, 2022
Source: fda.gov
525
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Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator.... See More The Life2000 system is manufactured by Hillrom, which was acquired by Baxter in late 2021. The Life2000 System is distributed in the United States.
Low oxygen saturation may lead to symptoms such as shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent impairment may occur if patients or caregivers do not recognize lower oxygen levels. Scenarios that could lead to oxygen desaturation include hoses that are kinked or have excessive moisture; modified, extended or loose/disconnected tubing; oxygen liter flow from the concentrator that has fallen below the prescribed level while using the Life2000 system; and/or non-compliance with recommended cleaning and maintenance of the Life2000 system and oxygen concentrator. Baxter has received reports of patient desaturation that required hospitalization. Based on analysis to date, no deaths have been reported related to this issue.
As described in the Urgent Medical Device Correction issued on January 25, 2023, patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements as detailed in the patient letter and Instructions for Use for both the Life2000 Ventilation System and third-party oxygen concentrators. These actions will help ensure the best oxygen delivery with the Life2000 system when used with a third-party oxygen concentrator. Baxter is continuing to monitor and investigate reports received and is currently investigating improvement opportunities.
Baxter will issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue. This Urgent Medical Device Correction applies to all Life2000 Ventilation Systems used with an oxygen concentrator, including the Life2000 Ventilator Packaged (BT-20-0002); the Life2000 Ventilator Packaged A (BT-20-0002A); the Life2000 System AC Package (BT200007); the Breathe Life2000 Ventilator PA (BT-20-0007); the Life2000 System HC Package (BT200011); the Breathe Technology Life2000 VE (BT-20-0011); and the Life2000 Ventilator V6.X (MS-01-0118).
Baxter is voluntarily issuing this Urgent Medical Device Correction and the U.S. Food and Drug Administration has been notified of this action.
Company name: Baxter International Inc.
Brand name: Life2000
Product recalled: Life2000 Ventilation System
Reason of the recall: Potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator
FDA Recall date: March 10, 2023
Source: fda.gov See Less
524
Purina Pro Plan Veterinary Diets EL Elemental - recalled due to elevated Ingredient level, USA
2 weeks ago
Nestlé Purina PetCare Company is expanding its voluntary recall of Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food due to a supplier error resulting in potentially elevated levels of vitamin D in two additional product lots, which precede the production dates of... See More the previously recalled lots. The original announcement was made on February 8, 2023. No other Purina pet care products are affected.
The expansion comes following an investigation prompted by Purina that uncovered new information about a production error from a U.S. supplier that was made only to this specific formula and resulted in potentially elevated levels of vitamin D. Vitamin D is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the level of vitamin D and the length of exposure. Vitamin D toxicity may include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling to renal (kidney) dysfunction. A list of the additional impacted product is below. Bags of PPVD EL with the UPC Code and Production Code below should be immediately discarded.
Product: Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL)
UPC Code (*First 8 characters equal to): 38100 19190 – 8 lb / Production Code: 2213 1082 (NEW)
UPC Code (*First 8 characters equal to): 38100 19192 – 20 lb / Production Code: 2214 1082 (NEW)
The affected dry dog food was distributed throughout the United States by prescription only through veterinary clinics, Purina Vet Direct, Purina for Professionals, and other select retailers with the ability to validate a prescription.
Pet owners who purchased bags of the product listed above are asked to immediately stop feeding and throw it away in a container where no other animals, including wildlife, can get to it. If signs such as weight loss, excessive drooling, vomiting, loss of appetite or increased thirst or urination have occurred in their dog while eating this diet, pet owners should contact their veterinarian.
Veterinary and other retail partners should remove and destroy the affected product from their inventory.
In case your pet experiences harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Nestle Purina PetCare Company
Brand name: Purina
Product recalled: Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food
Reason of the recall: Potential Elevated Ingredient Level
FDA Recall date: March 10, 2023
Source: fda.gov See Less
524
Omega-3 Supplements for cats and dogs - recalled due to elevated levels of vitamin A, USA
2 weeks ago
Stratford Care USA, Inc of Odessa, Florida is recalling multiple brands of Omega-3 Supplements for cats and dogs due to potentially elevated levels of Vitamin A. Vitamin A is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the... See More level of Vitamin A and the length of exposure. Omega-3 Supplements for cats and dogs was distributed throughout the United States in Veterinary Clinics, Distribution Centers, Retail Stores, and Online Market Places such as Amazon and Chewy.
Vitamin A toxicity may include general malaise, anorexia, nausea, peeling skin, weakness, tremors, convulsions, paralysis, and death. Stratford Care USA, Inc is taking this action after receiving a single Serious Adverse Event from a sole consumer regarding their dogs’ exhibiting signs of Vitamin A toxicity after consuming the supplement. This is the only Adverse Event to date.
Currently, Stratford Care USA, Inc in collaboration with the FDA is removing all products with these lot numbers from the market. No other Stratford Care USA, Inc products are affected. The white plastic container containing 60 soft gels has the marking on the bottom of the container that states “lot 31133 EXP 04/13/23” and “lot 30837 EXP 10/26/22”, this product has been private labeled under various brand names.
Affected products:
- Brand Name: All Creatures Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: All Veterinary Supply, INC. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Jungle Pet. Product Name: Skin+Coat Omega-3 Soft Gels. UPC (If Applicable): 85000395223.
- Brand Name: Animal Medical Clinic. Product Name: Omega V3 Softgels. UPC (If Applicable): 169682510808.
- Brand Name: Animal Medical Clinic Melbourne Beach. Product Name: Omega V3 Softgels. UPC (If Applicable): .
- Brand Name: Animal Care Hospital. Product Name: Omega-3 Fatty Acid Max Strength Soft Gels. UPC (If Applicable): NA.
- Brand Name: Animal Medical Center. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Barnes Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Brentwood Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Cherokee Trail Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Clinton Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Clyde’s Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Coastal Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Columbia Hospital For Animals. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Compassion Veterinary Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Doc Ladue’s. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Dogwood Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Doral Centre Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Eagles Landing Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Pet Health Solutions. Product Name: Omega Caps. UPC (If Applicable): 814087005489.
- Brand Name: SPCA of North Brevard. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): .
- Brand Name: LaVale Veterinary Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Twin Maples. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: University Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Venice Pines Veterinary Clinic. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Lake Dow Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: MVH Mann Veterinary Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: All Paws Animal Clinic Royal Palm Beach. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Bottle Tree Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Brookwood Veterinary Clinic. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Cleveland Park Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Crown Heights Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Eagle’s Landing Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: LVH Veterinary. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Mt Orab Veterinary Clinic. Product Name: Dr. Hayes’s Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Oak Tree Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Patterson Veterinary Hospital – Mason. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Prospect Heights Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Smyth County Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Stateline Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: The Pet Clinic of Urbana, LLC. Product Name: Omega-V3 Softgel. UPC (If Applicable): NA.
- Brand Name: Valdosta Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Viking Community Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Westbrook Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: My Pet Hospital. Product Name: Omega-3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: North Shore Animal League America. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: NPC Northgate Pet Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Northwest Tennessee Veterinary Services. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Pawstruck.com. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): 850005963080.
- Brand Name: Perry Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Pleasant Plains Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Seiler Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Stratford Animal Health. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Summerfields Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: SensoVet Animal Health Wellness. Product Name: Advanced Omega-3 Softgel. UPC (If Applicable): NA.
- Brand Name: University Animal Hospital. Product Name: Omega-V3 Softgels\. UPC (If Applicable): NA.
- Brand Name: Vet4Bulldog. Product Name: V4B Bully Fish oil omega-3 EFA. UPC (If Applicable): 603981565911.
- Brand Name: Waggin’ Wheel Vet Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Wellsboro Small Animal Hospital Veterinary Medical Center. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Wickham Road Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Wilton Manors Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
In case your pet experiences harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Stratford Care USA, Inc
Brand name: Multiple brands
Product recalled: Omega-3 Supplements for cats and dogs
Reason of the recall: Potential elevated levels of Vitamin A
FDA Recall date: March 10, 2023
Source: fda.gov See Less
524
Dr Rima Recommends Nano Silver dietary supplement - recalled due to unsubstantiated health claims, USA
2 weeks ago
CUSTOMERS OF NATURAL SOLUTIONS FOUNDATION (the “Foundation”) This is to inform you of a voluntary product recall involving the following Foundation product (the “Product”) “DR. RIMA RECOMMENDS NANO SILVER 10 PPM” The Product label is depicted for your reference and ease in identifying the Product. This recall... See More has been initiated because the Product is labeled as a dietary supplement that, in the opinion of the government, makes unsubstantiated health claims that the product will prevent, treat, or cure COVID-19. It is the government's position that consumers who use this product instead of seeking timely medical treatment run the risk of serious, life-threatening health consequences.
The Product was sold January 22, 2020 to December 27, 2021. Please examine your inventory to see whether or not you possess any Product subject to this recall and immediately cease distribution. If the Product has been further distributed, kindly identify all such persons so that we can make them aware of the Product recall. You are encouraged to notify your customers that the Product recall is occurring, and to provide them with a copy of this Notice. This recall should be carried out to the consumer level.
Company name: Natural Solutions Foundation
Brand name: Dr Rima Recommends
Product recalled: Dr Rima Recommends Nano Silver 10ppm dietary supplement
Reason of the recall: Product makes unsubstantiated health claims to prevent, treat, or cure COVID-19
FDA Recall date: March 08, 2023
Source: fda.gov See Less
524
Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. Product... See More was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).
Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles.
The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels attached.
Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Pharmedica USA LLC
Brand name: Purely Soothing
Product recalled: 15% MSM Drops
Reason of the recall: Non-sterility
FDA Recall date: March 03, 2023
Source: fda.gov See Less
524
Boil Water Advisory, Pottsboro, Texas, USA
9 hours ago
Texas Water Utilities has issued a boil water notice for customers in the Tanglewood on Texoma water system. According to a press release, the boil water notice issued for the city of Pottsboro Thursday that affects customers in Tanglewood.
Source: twitter.com
Published: 2023-03-24 See Less
Hardy Country PSD has LIFTED the boil water advisory for Hawk Tree Drive, Huffman Road, and a small section of Mountain View Road.
Source: twitter.com
Published: 2023-03-24 See Less
The City of Fairmont Water Department LIFTED the boil water advisory for Gilbob St., Tee St., Golf Dr., Fairway Lane and the surrounding area.
Source: twitter.com
Published: 2023-03-24 See Less
Raleigh County PSD has LIFTED the boil water advisory for Arnett (Dingess Branch).
Source: twitter.com
Published: 2023-03-24 See Less
As of 10:30 a.m. Warren RECC restored power outages in it’s coverage area after reaching over 3,000 outages earlier this morning. According to the power provider’s outage map, most of the outages were off Nashville Road in the neighborhoods off Bennett Lane and near Basil Griffin Park... See More and Three Springs Road.
Outage link: http://12.153.21.72:82/
Source: wbko.com
Published: 2023-03-24 See Less
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