Brand Name: Bisaf Strep A Self-Test — Class II medical device recall Z-1561-2026
Ongoing recall by Altruan GmbH, reported 2026-03-18, distributed nationwide. Product not cleared by the FDA.
| Recall number | Z-1561-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Altruan GmbH, Massing, N/A, Germany |
| Recall initiated | 2025-12-19 |
| Classified | 2026-03-12 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 188 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 06952804827274 |
| Model numbers | AL-42153 |
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Reason for recall
Product not cleared by the FDA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1561-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.