USA Medical recalls SARS-CoV-2 antigen rapid tests that lack FDA emergency use authorization. These tests are not approved for commercial distribution and may not be reliable for COVID-19 detection.
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
USA Medical is recalling SARS-CoV-2 antigen rapid tests that were not approved by the FDA for emergency use or commercial distribution. Using these tests could lead to inaccurate results and unreliable COVID-19 detection.
These tests were not cleared or approved by the FDA for emergency use or commercial distribution. Without proper authorization, they may not work correctly for detecting COVID-19, leading to unreliable results.
Anyone who purchased or uses these unapproved SARS-CoV-2 antigen rapid tests. People relying on these tests for COVID-19 screening may face inaccurate results.
The product is labeled as 'Diagnostic Kit SARS-cCo V Antigen Rapid Test' with no catalog/model/part number or UDI code. Lot numbers are unknown and not provided.
Look for the product name and any available identifiers like catalog numbers or lot numbers.
No, these tests were not cleared or approved by the FDA for emergency use or commercial distribution.
The product is labeled as 'Diagnostic Kit SARS-cCo V Antigen Rapid Test' with no catalog/model/part number or UDI code. Lot numbers are unknown and not provided.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send USA Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1050-2022 — USA Medical USA Medical Hello, I own a USA Medical that is covered by recall Z-1050-2022 from USA Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
