FDA DevicesClass II
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal...
Published: March 18, 2026Recall ID: Z-1561-2026Category: devicesCountry: US
Reason for Recall / Hazard
Product not cleared by the FDA.
Product Description & Identification
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Additional Source Details
| Field | Value |
|---|---|
| City | Massing |
| State | N/A |
| Event id | 98472 |
| Address 1 | Morolding 6 |
| Address 2 | N/A |
| Code info | Model No. AL-42153; No UDI; Lot Code: 6952804827274. |
| Postal code | N/A |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 188 units |
| Reason for recall | Product not cleared by the FDA. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Other |
| Center classification date | 20260312 |
Overview
- Recalling FirmAltruan GmbH
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.