More than 56,000 COVID-19 antigen rapid tests are being recalled because they may provide inaccurate results, according to federal health officials.
Universal Meditech Inc., which initiated the nationwide recall, discovered that the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits were “distributed without appropriate premarket clearance or approval,” according to a notice posted by the Food and Drug Administration.
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This “potentially could result in inaccurate test results due to lack of performance evaluation by the FDA,” the notice said.
Consumers are told to “immediately” stop using the recalled product and contact the distributor to return it, according to the notice.
The products were manufactured between October 2021 and December 2021. Universal Meditech sent the products to distributors in California and Texas. They were distributed in January 2022, officials said.
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Universal Meditech discovered that the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits were “distributed without appropriate premarket clearance or approval.”FDA/Universal Meditech Inc.
The company has been notifying both distributors and customers about the recall and is arranging for the return of all recalled products.
There haven’t been any injuries related to the recalled product. Still, officials say that any adverse reactions or quality problems that have been experienced with the product can be reported to the FDA’s MedWatch Adverse Event Reporting program.
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Antigen tests are able to produce test results within 15 to 30 minutes. Although they are rapid, they are less reliable than nucleic acid amplification tests, such as PCR-based tests, “especially for people who do not have symptoms,” according to the Centers for Disease Control and Prevention.
