Widely-Used Covid Tests Recalled For Relaying False Results
Universal Meditech's Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits are being recalled on the suspicion that they could provide inaccurate test results due to them being released without official FDA approval.
Since we are in the heart of cold winter weather, many people around the country are concerned about catching Covid. But there is important news for anyone still buying at-home Covid tests. One of the manufacturers of these kits just had to issue a recall for tens of thousands of its at-home tests.
Universal Meditech is one of the many companies producing rapid Covid tests for individuals to use at home when they begin feeling under the weather. Their product is Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit. However, the company failed to get approval from the Food and Drug Administration (FDA) before releasing the test kits onto the market, which is troubling news.
Consumer Affairs notes, “According to the U.S. Food and Drug Administration (FDA), the products were found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.” While there is no clear indication that the tests are providing faulty results, we simply do not know, thanks to the lack of testing. So the FDA sent Universal Meditech a notice that it violated standard regulations.
After receiving the notice, the company issued a voluntary recall of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit. So check your cupboards and medicine cabinet to see if you have one on hand. If so, here is what you need to know.
Universal Meditech produced the 56,300 Covid tests involved in the recall. However, the tests went out in three different box styles. Look for one of the following items.
The “DiagnosUS” brand Covid tests come in a green and white box. The “Skippack Medical Lab” brand kits are in a purple and white box. And an unbranded white box is the third style under recall.
All three came complete with leaflets for “Instructions for Use” that bear the “Skippack Medical Lab” brand instructions. Additionally, all recalled Covid tests got manufactured between October and December 2021. Then, distribution to stores started in January 2022.
But since it has been an entire year, the chances are high that if you had one of these tests, you already used it. So the company has provided the contact information for its attorney, who is happy to field any questions. You may reach the attorney via phone at (702)871-9888 between 9 a.m. and 5 p.m. PST, or via email at [email protected].
Contact the distributor directly should you still happen to have one of these tests stashed away. They are asking that impacted Covid tests get returned. But there is no word on how a refund process would work or which distributor customers should reach out to.
The good news is that no reported injuries are linked to the recall of these Covid antigen tests. However, that is not much consolation for anyone who trusted the results from these particular Covid tests. Thankfully, winter is over soon, and hopefully, it will take the last of Covid with it when it goes.
