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Coronavirus - Covid-19
Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results, USA
3 months ago
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,... See More 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 See Less
Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing) - recalled due to Unauthorized U.S. distribution, USA
1 year ago
ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” ACON Laboratories is not importing... See More the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” into the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. This press release serves as public announcement that this CE marked product is being recalled from the U.S. market.
The “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” cannot be legally imported, distributed, or used in the U.S. market as it has not been approved, cleared, or authorized by the FDA. The “Flowflex COVID-19 Antigen Home Test” cannot be legally imported, distributed, or used in the European market as it is not CE marked. These two products have been authorized by the U.S. FDA and registered under CE Mark authorities separately under different product registration requirements, and therefore:
- This recall shall have no impact on the distribution and use of the CE marked “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” in Europe and other markets outside of the U.S.
- This recall shall have no impact on the distribution and use of the FDA authorized “Flowflex COVID-19 Antigen Home Test” in the United States.
Risk Statement: COVID-19 Antigen tests in the U.S. market that lack FDA approval, clearance, or authorization can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results. COVID-19 Antigen tests in Europe without the CE mark can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results.
False-negative antigen test results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are grouped into cohorts (that is, they are housed together) in health care, long-term care, and other facilities based on these false test results.
Actions to limit exposure based on false-negative results might not be taken, such as isolating people, limiting contact with family and friends, and limiting ability to work. False-positive antigen test results may lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together).
To date, ACON Laboratories has not received any reports of adverse events related to the products addressed in this public press release and is issuing this recall out of an abundance of caution.
If you have received the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” with the blue box in the U.S. market, you should stop using this product and dispose of it. The product has not been approved, cleared, or authorized for use in the U.S. To help differentiate the recalled product from the FDA authorized product, please find the table below, highlighting differences in the product kit box labeling. Note that the CE marked product has “ACON Biotech (Hangzhou) Co., Ltd.” as the manufacturer in place of “ACON Laboratories, Inc.”
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Not FDA Authorized (Recalled Product)
- Flowflex COVID-19 Antigen Home Test | FDA Authorized
Please see the pictures of the products below. ACON is working closely with the FDA and other law enforcement agencies to ensure that only the FDA authorized “Flowflex COVID-19 Antigen Home Test” is distributed in the U.S. Any distribution of the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” should be reported immediately to ACON Laboratories and the FDA at the numbers provided below.
Company name: ACON Laboratories, Inc.
Brand name: Flowflex™
Product recalled: SARS-CoV-2 Antigen Rapid Test (Self-Testing)
Reason of the recall: Unauthorized U.S. distribution-counterfeited product
FDA Recall date: March 11, 2022
Check the full recall details on fda.gov
Source: FDA See Less
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