There is still a considerable demand for COVID-19 tests, and there are several at-home options. But not all COVID-19 tests are equal. Late last year, millions were recalled as they didn’t seem as reliable as expected.
Investigations had also uncovered fake tests sold at a premium when at-home devices were hard to come by. That has thankfully diminished, but plenty of unauthorized tests are still on shelves.
Read on for one such test that the FDA warns against using and why you should always double-check the authenticity.
Here’s the backstory
At-home COVID-19 tests are easier to get these days, but not all are authorized for use in the U.S. The Food and Drug Administration (FDA) warns against using a specific ACON Biotech Flowflex at-home test in a public health warning.
The agency explains that you shouldn’t use the test that comes in a dark blue box, as it “has not been authorized, cleared, or approved by the FDA for distribution or use in the United States.” Since it isn’t approved for use, the FDA can’t be confident about the accuracy of the test result.
The full name of the unauthorized at-home test is ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). While the version in a white box has emergency use authorization from the FDA, the dark blue box does not.
What you can do about it
The FDA reiterates that a false positive antigen result can lead to you not getting the proper treatment if you have a different illness or delay appropriate treatment.
In addition, a false-negative test can further spread the virus as you would assume that you are in the clear. But if you have COVID, it will also delay proper medical treatment.
What should you do if you have the unauthorized test in your home or took it recently? The FDA’s advice is to throw the test away and not use it. However, you should retake the test with an FDA-authorized kit.
Remember that you can still order your four free at-home tests from the government if you haven’t already done so. Tap or click here to find out how. The tests are cleared with the FDA and shipped to you at no charge. Here are more tips for making sure your test is legitimate:
- Check out the FDA’s lists of antigen diagnostic tests and molecular diagnostic tests if you are concerned about a test you have at home.
- The FDA has also put together a list of known fraudulent COVID-19 products that you should know and what to avoid.
- Know the places you’re most likely to get COVID and try to avoid them at all costs.
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have regarding a medical condition, advice, or health objectives.