Reported Mar 18, 2026 · Ongoing
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Altruan GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Altruan GmbH · Morolding 6 · Massing, N/A · N/A
Is this the product you have?
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
- Lot codes and dates
- Model No. SP-C310343-10; No UDI
- Lot Code01242573
- Amount recalled
- 188 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Product not cleared by the FDA.
This product could cause temporary or reversible health problems — stop using it.
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