COVID test recall overview:
- Who: Universal Meditech Inc. has recalled 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits.
- Why: The product was distributed without proper federal clearance.
- Where: The COVID tests recall is active nationwide.
Universal Meditech Inc. has issued a recall of more than 50,000 COVID test kits, as the product was distributed without the proper federal clearance.
The recall was published to the company’s website Jan. 16 and applies to 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits.
According to the recall, 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,” they said.
It is not the first time the FDA has recalled a COVID test. Last year, the FDA issued a Type 1 recall, its most serious type, for lots of an Accula-brand COVID-19 test as the tests may provide false positive results.
To date, there has not been any reported effect of using these recalled COVID tests, the company said. It is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.
Stop using the COVID tests immediately, recall states
Consumers who have Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits should stop using them immediately and contact the distributor for a product return, the recall states.
Recalled products were manufactured from October 2021 to December 2021 and were distributed in January 2022 in Texas and California.
They were distributed with a Skippack Medical Lab-branded instruction leaflet in three different packaging boxes under the brands “Skippack Medical Lab,” “DiagnosUS” or in a white box without a brand name. Photos of the products can be seen here.
Universal Meditech Inc. is notifying its distributors and customers by phone and email and is arranging for return of all recalled products.
Are you affected by this recall? Let us know in the comments.
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14 thoughts on56K COVID tests recalled due to lack of FDA approval
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Yes I used this product and had a false test but felt like it was incorrect and when I went to the hospital to have another test I was positive for COVID-19 and got so bad I was hospitalized and gave it several of my elderly family members and my premature twins
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