Z-1560-2026Class II

Altruan GmbH

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Altruan GmbH

Product type

Device

Status

Ongoing

Report date

2026-03-18

Distribution

US Nationwide distribution.

Firm state

N/A

Product quantity

188 units

Initiated by

Voluntary: Firm initiated

Reason for recall

Product not cleared by the FDA.

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →