FDA Medical devices recall ·
Bisaf Strep A Self-Test recall
- Recall number
- Z-1561-2026
- Date
- (initiated December 19, 2025)
- Company / brand
- Altruan GmbH
Morolding 6, Massing, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 188 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Why was it recalled?
Product not cleared by the FDA.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1561-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.