Altruan GmbH: Medical Device Recall in 2026 - (Recall #: Z-1561-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 19, 2025

Date Posted: March 18, 2026

Recall Number: Z-1561-2026

Event ID: 98472

Reason for Recall:

Product not cleared by the FDA.

Status: Ongoing

Product Quantity: 188 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated