FDAClass IIMarch 18, 2026

Clearest Strep-A Cassette Test. Test to determine the recall

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

Why was Clearest Strep-A Cassette Test. Test to determine the recalled?

Product not cleared by the FDA.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Recalling firm
Altruan GmbH
Quantity
188 units
Distribution
US Nationwide distribution.
Recall date
March 18, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls