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Flowflex SARS-COV-2 Rapid Test Recall Overview:
- Who: Approximately 200,100 Flowflex SARS-COV-2 Antigen Rapid Tests (Self-Testing) have been recalled by the Food and Drug Administration.
- What: The tests are being recalled because they were never granted approval by the regulatory agency
- Where: The recall is nationwide.
Approximately 200,100 Flowflex SARS-COV-2 Antigen Rapid Tests (Self-Testing) have been recalled by the Food and Drug Administration (FDA) as the tests were never granted approval by the agency.
In a recall notice, the FDA says the tests have not been authorized for emergency use to test for COVID-19 and “cannot be determined to be adequately validated for the stated intended use.”
In the notice, it says the product lot codes are COV1080232 – expiration date: 05/13/2023 and COV1095004 – expiration date: 09/03/2023.
The test, which comes in a blue box, is not to be confused with the FDA-approved “Flowflex™ COVID-19 Antigen Home Test,” which comes in a white box.
Although approved in Europe and other markets, the Flowflex SARS-COV-2 Antigen Rapid Tests (Self-Testing) has not been approved in the United States but has crept into circulation at an unknown number of pharmacies, according to NBC News.
Consumers Urged to Discard Tests, Get New COVID-19 Test
The FDA is urging consumers to inspect their stock of COVID-19 tests and discard any of the recalled products in their possession.
“If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect,” the agency says. “It is recommended that you obtain a confirmatory test to determine your SARS-CoV-2 infection status.”
According to NBC, the manufacturer of the FDA-approved Flowflex tests, ACON Laboratories, is aware of the “unauthorized, adulterated and misbranded counterfeit product.”
“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,” a statement from the manufacturer said.
In November, more than 2.2 million at-home COVID-19 tests made by Australian company Ellume were recalled by the FDA in a Class 1 recall—the agency’s most serious type of recall. The tests were recalled because they had higher-than-acceptable false positive test results for COVID-19, the recall says. The reliability of negative tests is not affected.
Tell us what brand of COVID-19 tests you use at your home in the comments section below!
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6 thoughts onRecall Check: More Than 200K Non-FDA Approved Flowflex COVID-19 Tests Recalled
I had an issue with these test I had sold some before the recall and am being sued because of it how do I sue acon
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We purchased also,
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Add me to this I bought some last week.