Innova Medical recalls SARS-CoV-2 antigen rapid tests distributed to non-clinical customers. These tests may be used for in vitro diagnostics but were sent to customers outside clinical studies.
Due to distributing test kits to customers who were not part of a clinical investigation.
Innova Medical is recalling SARS-CoV-2 antigen rapid tests that were distributed to customers who were not part of a clinical study. This recall is because the tests were sent to people outside of approved clinical investigations.
The tests were distributed to customers who were not part of a clinical investigation. This means they may not have been properly validated for use outside of clinical settings. The hazard is related to improper use in non-clinical environments.
People who purchased these specific SARS-CoV-2 antigen rapid tests from the listed lot numbers. Those using the tests outside of clinical settings are most at risk.
Check the lot numbers listed: U2101750, U2101751, X2006004, X2008001, X2008001, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, X2011005, X2011006, X2011007, X2011008, X2011009, X2011012, X2011013, X2011015, X2011016, X2011017, X2011025, X2011051, X2011052, X2012001, X2012002, X2012004, X2012005, X2012008, X2101002, X2101004, X2101014, X2101031, X2101038. The product is a SARS-CoV-2 antigen rapid test for in vitro use.
Look for the lot numbers listed in the recall: U2101750, U2101751, X2006004, X2008001, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, X2011005, X2011006, X2011007, X2011008, X2011009, X2011012, X2011013, X2011015, X2011016, X2011017, X2011025, X2011051, X2011052, X2012001, X2012002, X2012004, X2012005, X2012008, X2101002, X2101004, X2101014, X2101031, X2101038.
Innova Medical is recalling SARS-CoV-2 antigen rapid tests that were distributed to customers who were not part of a clinical investigation.
Check the lot numbers listed: U2101750, U2101751, X2006004, X2008001, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, X2011005, X2011006, X2011007, X2011008, X2011009, X2011012, X2011013, X2011015, X2011016, X2011017, X2011025, X2011051, X2011052, X2012001, X2012002, X2012004, X2012005, X2012008, X2101002, X2101004, X2101014, X2101031, X2101038.
The recall does not specify a remedy, so there is no action required beyond checking if your product has a listed lot number.
We’ve drafted a message you can send Innova Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1538-2021 — Innova Medical Innova Medical Hello, I own a Innova Medical that is covered by recall Z-1538-2021 from Innova 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.
