Altruan GmbH recalls Bisaf Strep A Self-Test kits due to not being cleared by the FDA. Affected units include model AL-42153 sold with lot code 6952804827274.
Product not cleared by the FDA.
Altr: The Bisaf Strep A Self-Test kits were recalled because they were not cleared by the FDA. This means they may not be safe for use as intended.
The product was not cleared by the FDA, meaning it may not meet safety standards for use. This could lead to inaccurate results or potential health risks if used improperly.
People who purchased the Bisaf Strep A Self-Test kits with model number AL-42153 and lot code 6952804827274 are affected. Those using the test for strep throat detection are at risk.
Check for the model number AL-42153 and lot code 6952804827274 on the product packaging. The Bisaf Strep A Self-Test is designed for throat swab testing for group A strep.
Look for model number AL-42153 and lot code 6952804827274 on the packaging.
The product was not cleared by the FDA, meaning it may not meet safety standards for use.
The recall record does not specify a remedy, so check with the manufacturer for guidance.
The product was not cleared by the FDA, so it may not be safe for use as intended.
We’ve drafted a message you can send Bisaf to request your refund or repair — edit it as you like.
Subject: Recall Z-1561-2026 — Bisaf Bisaf Hello, I own a Bisaf that is covered by recall Z-1561-2026 from Bisaf. 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.
