Altruan recalls Clearest Strep-A Cassette Test due to not being cleared by the FDA. This test for group A streptococci in throat swabs may pose risks if used without proper approval.
Product not cleared by the FDA.
Altr: The Clearest Strep-A Cassette Test, which detects group A streptococci in throat swabs, has been recalled because it was not cleared by the FDA. This means the product may not be safe for use without regulatory approval.
The product was not cleared by the FDA, meaning it lacks required safety and effectiveness standards. Using unapproved medical devices can lead to inaccurate results or health risks if misused.
People who purchased or use the Clearest Strep-A Cassette Test for throat swab testing are affected. Those with medical conditions requiring strep tests may be at higher risk.
Check for the model number SP-C310343-10 on the product. The recall applies to this specific test kit sold without a unique device identifier (UDI).
Verify the model number SP-C310343-10 on the test kit to confirm it is affected.
The FDA did not clear this product, so it may not be safe for medical use without approval.
The recall record does not specify a remedy, so check with the manufacturer for guidance.
Look for the model number SP-C310343-10 on the test kit.
We’ve drafted a message you can send Altruan to request your refund or repair — edit it as you like.
Subject: Recall Z-1560-2026 — Altruan Altruan Hello, I own a Altruan that is covered by recall Z-1560-2026 from Altruan. 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.
