FDA-Device2026-03-18Class IIMISBRANDING
Altruan Clearest Strep-A Cassette Test recalled — not FDA-cleared
What this means
Altruan GmbH distributed Clearest Strep-A Cassette Test kits that were not cleared or approved by the FDA before being sold. These tests are designed to detect group A streptococci (Strep A) in throat swab samples. About 188 units were distributed nationwide.
- Stop using the Clearest Strep-A Cassette Test if you have it
- Check your test kit lot code 01242573 or model SP-C310343-10
- Contact your healthcare provider or pharmacist for guidance on proper throat swab testing
- Do not rely on results from this test kit for medical decisions
The agency's original wording
Hazard
Product not cleared by the FDA.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
188 units
Manufactured in
Morolding 6, N/A, Massing, N/A, Germany
Products
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1560-2026Want us to check the next one for you?
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