Z-1561-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188 units
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model No. AL-42153; No UDI; Lot Code: 6952804827274.