Z-1561-2026Class II

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

Name: Z-1561-2026 Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs
Creator: Altruan GmbH
Published: 2025-12-19
License: https://open.fda.gov/license/

Altruan GmbH / initiated 2025-12-19 / Open, Classified

FDA source

Altruan GmbH began a recall of Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs on 2025-12-19. FDA classified it as Class II and gives the reason as "Product not cleared by the FDA". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1561-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-03-12
Recalling firm: Altruan GmbH
Product: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: Product not cleared by the FDA.
FDA root cause: No Marketing Application
Action: The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.
Quantity in commerce: 188 units
Distribution: US Nationwide distribution.
Product codes and lots: Model No. AL-42153; No UDI; Lot Code: 6952804827274.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1561-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1559-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-12
Z-1560-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-12
Z-1561-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-12

Product code GTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)