Class II
Medical Device Recall: Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Altruan GmbH · December 19, 2025
Reason for Recall
Product not cleared by the FDA.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
188 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1560-2026
Status: ongoing
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