Altruan GmbH: Medical Device Recall in 2026 - (Recall #: Z-1560-2026)

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:

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Product Classification:

Class II

Date Initiated: December 19, 2025

Date Posted: March 18, 2026

Recall Number: Z-1560-2026

Event ID: 98472

Reason for Recall:

Product not cleared by the FDA.

Status: Ongoing

Product Quantity: 188 units

Code Information:

Model No. SP-C310343-10; No UDI; Lot Code: 01242573.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated