Class IIReported 2026-03-18

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Recalled by Altruan GmbH

Reason for Recall

Product not cleared by the FDA.

Recall Number

Z-1561-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-03-18

Distribution

US Nationwide distribution.

Code Info

Model No. AL-42153; No UDI; Lot Code: 6952804827274.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.