⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-03-18

Read the official notice at FDA (device) →

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Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Altruan GmbH
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Reason / hazard
Product not cleared by the FDA.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-12-19
Code info
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Product quantity
188 units
Voluntary mandated
Voluntary: Firm initiated
City
Massing
State
N/A
Country
Germany
Event id
98472
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