Create a Report

Please provide report title
Please provide location
Please provide details

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Skip this step

Add photos or video

We recommend photos and videos to help explain your report

Add Photo/Video
Skip this step

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone
Please provide email or phone

Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by

Message us
WhatsApp
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect, USA

7 months ago •source www.fda.gov

Recall notice

Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect photo #1

United States

On May 22, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products. 4 of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips, HealthyWiser KetoFast™ Ketone Test Strips and DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test) have been violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. These products have been distributed to distributors in California, New York, New Jersey, and Florida, and they may have been further sold to end consumers national-wide across the United States. To date, there has not been any reported injury due to the use of any of the products.

Recalled products were manufactured and distributed from March 2021 to November 2022. The following styles/models/UDI have been recalled:

No. Product Name UDI Number Lot Number to be Recalled
1 One Step® Pregnancy Test B512100011 3-H25052-20UMI 3-H07102-20UMI
2 One Step® Ovulation Test* B512200011 3-L12121-20UMI 3-L07102-20UMI
3 HealthyWiser UriTest™ 10 Parameter Reagent Test Strips for Urinalysis None** URS-1-2104-01 URS-1-2102-02 URS-1-2105-01 URS-1-2106-02 URS-1-2110-02
4 HealthyWiser UriTest™ UTI Test Strips None** URS-1-2102-03 URS-1-2106-01 URS-1-2202-01-Q URS-1-2204-01 URS-1-2207-01 URS-1-2209-01
5 HealthyWiser KetoFast™ Ketone Test Strips None** URS-1-2104-02
6 HealthyWiser pH-Aware™ pH Test Strips None** URS-1-2105-01-Q URS-1-2105-02-Q URS-1-2108-01-Q URS-1-2109-01-Q URS-1-2111-01-Q
7 hCG Pregnancy Cassette None** hCG-M5-2101-01 hCG-M5-2104-01 hCG-M5-2106-01 hCG-M5-2107-01 hCG-M5-2108-01 hCG-M5-2110-01 hCG-M5-2202-01 hCG-M5-2202-02hCG-M5- 2202-03 hCG-M5-2203-01 hCG-M5-2204-01 hCG-M5-2204-02 hCG-M5-2204-03 hCG-M5-2206-01 hCG-M5-2206-02 hCG-M5-2207-01 hCG-M5-2210-02
8 Am I Pregnant Pregnancy Midstream Test None** hCG-MHM-2205-01 hCG-MHM-2207-01 hCG-MHM-2207-02 hCG-MHM-2207-03 hCG-MHM-2207-04 hCG-MHM-2208-01 hCG-MHM- 209-01 hCG-MHM-2209-02 hCG-MHM-2209-03 HCG-MHM-2210-01 HCG-MHM-2210-02
9 hCG Pregnancy Strips None** hCG-S-2210-03
10 PrestiBio™ Breastmilk Alcohol Test Strip None**
11 PrestiBio™ Ovulation Strips*** None** Any Lot Number
12 PrestiBio™ Ovulation and Pregnancy Strips None** Any Lot Number
13 PrestiBio™ Pregnancy Strips**** None** Any Lot Number
14 PrestiBio™ Rapid Detection Pregnancy Test Midstream None** Any Lot Number
15 PrestiBio™ Ketone Test Strips None** Any Lot Number
16 PrestiBio™ Urinalysis Test Strip None** Any Lot Number
17 DiagnosUS® One Step LH Ovulation Test (Strip) None** LH-S-2204-01-S LH-S-2111-01-S
18 DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test None** COV-UL-2208-01
19 DiagnosUS® One Step FSH Menopausal Test (Strip None** FSH-S-2106-01 FSH-S-2108-01 FSH -S-2111-01-S
20 Lem Fertility hCG Pregnancy Urine Test None** hCG -S-2112-02
21 Lem Fertility LH Ovulation Test (Strip) None** LH-S-2112-01
22 DiagnosUS® hCG Pregnancy Urine Test Strip Format None** hCG-S-2101-01 hCG-S-2111-01-S hCG-S-2112-01
23 DiagnosUS® hCG Pregnancy Urine Test Cassette Format None** hCG-M5-2103-01 hCG-M5-2106-02 hCG- M5-2109-01 hCG- M5-2203-01
24 DiagnosUS® hCG Pregnancy Serum/Urine Test Cassette Format None** hCG-M5-2106-03
25 DiagnosUS® Pregnancy Test Midstream 710928980000 hCG-M11-2103-01 hCG-M11-2105-01
26 DiagnosUS® Ovulation Predictor Midstream 697691538914 LH-M11-2101-01 LH-M11-2105-01 LH-M11-2106-01 LH-M11-2107-01

Consumers who still have unused tests manufactured by Universal Meditech Inc. should stop using the device immediately and discard any remaining stock in the trash, or ship back to Universal Meditech at our expense.

In case you experience 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. If symptoms persist, seek medical care.

Company name: Universal Meditech Inc.
Brand name: Healthy Wiser and more
Product recalled: Test kits
Reason of the recall: Product Safety/Defect
FDA Recall date: September 22, 2023

Source: www.fda.gov

#medicaldevices #us

303

Recent Interesting Reports

W

VERTI bioribose that was’t ordered, don’t need and don’t want., Dallas, GA, USA

1 week ago •reported by user-whpg7377

Received jar of VERTI bioribose that was’t ordered, don’t need and don’t want. It is not even a valid USPS TRACKING NUMBER. My main concern - was I charged for this? Is this some type of drug that “an unknown” is trying to get us to use. Many other ladies are in the same boat!

#unorderedpackage #delivery #uspostalservice #dallas #georgia #us

VERTI bioribose that was’t ordered, don’t need and don’t want. photo #1
70

Tejocote Dietary Supplements - recalled because it contains toxic yellow oleander, USA

2 weeks ago •source www.fda.gov

Recall notice

Global Mix, Inc. of New York, is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. The recalled products were distributed in the following states: AL, AK, … See More
CA, CO, CT, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NM, NC, NY, NJ, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, and WY through website. The recalled products were also sold via the below websites via courier direct delivery and mail order. Etsy, amazon, eva-nutrition, tejocotemexican, niwali, scienceofalpha. The recalling firm has not received any reported of illness.

Recalled Products include the following bearing below information. Product codes and expiration dates can be found on the bottom of the packaging.

Product Name: Eva Nutrition MexicanTejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Science of Alpha Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: NWL Nutra Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Niwali Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025

Per the safety alert update on 3/12/24, "The FDA continues to receive adverse event reports related to the products identified in this Safety Alert."

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the yellow oleander. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem. Further the company is conducting comprehensive quality control and monitoring process.

Customers who have purchased these products should stop using them immediately and return them to the point of purchase for a full refund.

Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Global Mix, Inc.
Brand name: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra
Product recalled: Tejocote Dietary Supplements
Reason of the recall: Product contains toxic yellow oleander.
FDA Recall date: April 10, 2024

Source: www.fda.gov
See Less

#recall #us

Tejocote Dietary Supplements - recalled because it contains toxic yellow oleander photo #1
303

Popular topics

#Lifted Boil Water Advisory #Power Outages #Boil Water Advisory #Drugs #Pet Food #Delivery #Starbucks #DreamBone Dog Treats #Online Scam #Unordered Package #Scam #First Energy #PG&E - Pacific Gas and Electric #Facebook Scam #Cedar Grove #Las Vegas
Last 30 days