Altruan GmbH recalls Wondfo Streptococcal A At-Home Self-Test due to not being cleared by the FDA. This at-home test for group A beta-hemolytic streptococcal infection may pose risks if used without regulatory approval.
Product not cleared by the FDA.
Altruan GmbH is recalling its Wondfo Streptococcal A At-Home Self-Test because it has not been cleared by the FDA. This means the test may not be safe or effective for home use without regulatory approval.
The product has not been cleared by the FDA, meaning it lacks required safety and effectiveness testing. Using an unapproved medical device at home could lead to incorrect results or health risks if misused.
Anyone who purchased the Wondfo Streptococcal A At-Home Self-Test. People using this test for group A beta-hemolytic streptococcal infection without FDA clearance are at risk.
Check for the model number 41972 on the product. The recall covers units sold with lot code 6933289812337.
Look for model number 41972 and lot code 6933289812337 on the product.
The FDA has not cleared this product for home use, so it may not be safe or effective.
The recall does not specify a remedy, so check with the manufacturer for guidance.
The product has not been cleared by the FDA, meaning it lacks required safety and effectiveness testing.
We’ve drafted a message you can send Wondfo to request your refund or repair — edit it as you like.
Subject: Recall Z-1559-2026 — Wondfo Wondfo Hello, I own a Wondfo that is covered by recall Z-1559-2026 from Wondfo. 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.
