Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci recall (Altruan GmbH)
Medical deviceClass IIOngoing
Summary: Altruan GmbH is recalling Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.. Reason: Product not cleared by the FDA.
What is being recalled
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Why
Product not cleared by the FDA.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1560-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 19, 2025 |
| Reported | March 18, 2026 |
| Company | Altruan GmbH |
| Company location | Massing, N/A, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 188 units |
More recalls from Altruan GmbH · all medical device recalls · recalls from December 2025