If You Have This COVID Test at Home, Throw It Out Immediately, FDA Warns
These unauthorized tests could pose "signifiant risk" to users.
Although COVID rapid tests for home use were scarce and hard to come by earlier in the omicron wave, the kits are again widely available and ubiquitous. High-risk individuals; people required to tests for events, school, or job duties; and anyone who's extra conscious about transmission likely has a stockpile of tests at home right now. If you do, you'll want to check your inventory: There's a new recall that affects at-home COVID rapid tests. Read on to learn which tests are being recalled, why, and what you should do if you have any in your personal stash.
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Flowflex SARS-CoV-2 Antigen Rapid Tests are being pulled from the U.S. market.
ACON Laboratories, the legal manufacturer of the Flowflex COVID-19 Antigen Home Test has discovered distribution around the U.S. of "unauthorized, adulterated, and misbranded counterfeit product" on the market, leading to this recall. According to a press release published on the U.S. Food & Drug Administration (FDA) website on Mar. 11, these products are selling with the trade name Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).
The recalled products are not authorized for sale in the U.S.
ACON Laboratories is not importing tests by this name into the U.S. as it is only authorized for sale in Europe and other markets. The FDA's notice serves as public announcement that this CE-marked product is being recalled from the U.S. market. It states that the product "cannot be legally imported, distributed, or used in the U.S. market as it has not been approved, cleared, or authorized by the FDA."
Similarly, 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 the recall doesn't impact the distribution and use of the CE-marked Flowflex SARS-CoV-2 Antigen Rapid Test Self-Testing kits in Europe and other markets outside of the U.S. Further, the recall has no impact on the distribution and use of the FDA authorized Flowflex COVID-19 Antigen Home Test in the United States.
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Use of the unapproved tests could pose "significant risk."
If you use a COVID antigen test in the U.S. that lacks FDA approval, clearance, or authorization, the test could "pose significant risk," since it could produce an inaccurate result including false negative or positive results. (And the same is true for tests in Europe without the CE mark.)
False-negative antigen test results may lead to delayed diagnosis or inappropriate treatment, which could "cause harm including serious illness and death," according to the press release, by spreading the virus when people who are presumed negative congregate based on these false test results.
On the flip side, false-positive antigen test results may lead to a delay in both the correct diagnosis and the initiation of appropriate treatment for the actual cause of a person's sickness, which could be a different life-threatening disease. False positives could also further spread of the virus when presumed positive people are grouped together.
Fortunately, ACON Laboratories has not received any reports of adverse events related to the products addressed in this public press release at this stage and is "issuing this recall out of an abundance of caution."
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Here's what to do if you have any of the recalled tests at home.
The Flowflex SARS-CoV-2 Antigen Rapid Test Self-Testing kits come in a blue box. If you have any of these in the U.S., stop using them and throw them away. The product has not been approved, cleared, or authorized for use in this country.
The differences in the recalled product and the FDA authorized product are subtle, but one way to differentiate is that the CE-marked product has ACON Biotech (Hangzhou) Co., Ltd. as the manufacturer in place of ACON Laboratories, Inc.
ACON is working closely with the FDA and other law enforcement agencies to ensure that only the FDA-authorized version is distributed in the U.S. So if you discover any unauthorized distribution, report it immediately to ACON Laboratories and the FDA.
Reach ACON by phone at 800-838-9502 or email at [email protected].
If you feel you might have experienced any adverse effects from using a recalled product, you can report it to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax after downloading the reporting form.
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