Flowflex Rapid Tests Recalled for Not Having U.S. Authorization – NBC New York

The common at-home COVID rapid test has become the subject of a recent product recall due to concerns that the antigen test will not receive proper authorization from the United States.

The FDA issued a recall request late last month for “Flowdrape SARS-CoV-2 Antigen Rapid Test (Self Test), “Product sold in an unknown number of pharmacies and distributed by local health officials. The easy-to-use home test has been approved in European and other markets, but has not received the emergency use authorization required by the US Department of Health. Food and medicine.

The withdrawal of the test, which the government estimates contains 200,000 in US circulation, may confuse consumers between the two flowsdrape Branded antigen tests.

It is packaged in a white box and given the appropriate emergency use permission ‘Flowdrape™ COVID-19 Antigen Home Test Certified in the US

A recall notice from ACON Laboratories identifies a rapid antigen test (left) in a recalled blue packaging, next to its US approved product (right) packaged in a white box.

Consumers who possess the test not authorized by the FDA are encouraged to discard the product, and if it has already been used to screen for potential COVID infection, request additional testing from a federally approved provider.

Manufacturer of Flowdrape ACON Labs, said it was aware of the “unauthorized, fraudulent, counterfeit misbranded product” and issued a recall on January 9.

A statement issued by the manufacturer this week said: “Tests for COVID-19 antigens in the US market that lack FDA approval, authorization or authorization can pose a significant risk as they may lead to inaccurate test results, including negative test results. false or false positive. .

ACON has released a side-by-side comparison of the two products in hopes of helping US consumers distinguish between a recalled test and a test allowed for emergency use.

As of this week, the manufacturer said it had received no reports of “adverse events” related to either test and issued the recall “out of great caution.”

The recall caught the attention of public health officials in at least one county in New York, who issued a notice to residents on Friday.

The Orange County government postponed the previously scheduled distribution of planned recall tests for Monroe, and announced that anyone who received the test at the Wallkill and New Windsor events can replace their antigen test with a new one at a later event.


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