Altruan GmbH
Device Recalls (Class II)
Class II
Z-1560-2026
·
20260318
·
Ongoing
Product
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Reason for Recall
Product not cleared by the FDA.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API