← FDA ENFORCEMENT
Z-1561-2026Class II
Altruan GmbH
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Altruan GmbH
Product type
Device
Status
Ongoing
Report date
2026-03-18
Distribution
US Nationwide distribution.
Firm state
N/A
Product quantity
188 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Product not cleared by the FDA.
Product description
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Code / lot info
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →