A COVID test is an essential kit to tell you if you have the coronavirus or not. It’s a welcome sight to know that it’s now widely available for home use.
Now, you can check if anyone in your family has the dreaded virus if they show symptoms. However, FDA warns about this particular rapid test because it’s a subject of a recall.
Kindly read on to learn more.
1. ACON Laboratories Recalls Flowflex Antigen Rapid Test
The Flowflex manufacturer recently discovered a proliferation of their product in the U.S. market. However, it claims that the COVID test for home use is a counterfeit product; thus, ACON Laboratories recalls them. The FDA published the press release on its website on March 11.
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2. Unauthorized Sale of Flowflex COVID Test for Home Use
According to ACON, the company doesn’t import this COVID testing kit using the name Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) because only Europe and other markets have the authorization to market the said testing kit.
Therefore, the FDA instructs the public to return the said product because it hasn’t been cleared, approved, or authorized by the government agency.
3. Using the COVID Test Can Be Risky
Check your inventory if you have the said COVID testing kit that can pose a risk because its outcome may include false positive or false negative.
If you use the said antigen test kit that shows a false negative result, you may not think you don’t have the virus; thus, you may get an inappropriate treatment or delayed diagnosis that can prove harmful.
For example, you may continue to spread the virus because of a false-negative test outcome. Moreover, you may experience a severe illness or worse.
On the other hand, if you get a false-positive test result, you also delay the proper diagnosis and treatment. It’s also a life-threatening scenario because medical personnel may group you with truly positive COVID patients.
It’s good news that ACON Laboratories hasn’t received any product-related issues; thus, you must immediately return or dispose of the product.
4. Take the following Advice if You Use the Recalled COVID Test at Home
If you have the Flowflex antigen COVID test kit in a blue box at home, you should discard it immediately because the FDA didn’t clear, authorize, or approve its use. The FDA-approved kit has a CE-mark with ACON Biotech (Hangzhou) CO., LTD.
As the maker, instead of ACON Laboratories, Inc., ACON now coordinates with FDA and law enforcement agencies to ensure that only its cleared version finds its way in the U.S. market.
If you know of any unauthorized distributor, you may report the matter to the FDA. You may also contact ACON Laboratories at the following:
- Telephone: 800-838-9502
- Email: flowflex_support@aconlabs.com
Moreover, you should report to the MedWatch Adverse Event Reporting system f you have any adverse effects from the recalled COVID test for home use.
Final Thoughts
Now that a COVID test is available for testing at home, you should be careful about using a product that the FDA doesn’t clear, authorize, or approve.
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If you have the recalled product from ACON Laboratories, you must dispose of it immediately. Moreover, you should report to FDA or ACON if you know of anyone illegally distributing it.
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