Class IIOngoingZ-2169-2026
Quidel Corporation recalls QuickVue Dipstick Strep A Test
Product has the potential for false positive results
Quidel CorporationCAMay 20, 2026
Antigens, All Groups, Streptococcus Spp. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–6 of 6 recalls
Class IIOngoingZ-1561-2026
Altruan GmbH recalls Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antige…
Product not cleared by the FDA.
Altruan GmbHMar 18, 2026
Class IIOngoingZ-1560-2026
Altruan GmbH recalls Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci…
Product not cleared by the FDA.
Altruan GmbHMar 18, 2026
Class IIOngoingZ-1559-2026
Altruan GmbH recalls Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic strep…
Product not cleared by the FDA.
Altruan GmbHMar 18, 2026
Class IIOngoingZ-2545-2025
Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T
Dipstick strep A test has potential for false positive results.
Quidel CorporationCASep 17, 2025
Class IIOngoingZ-2337-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls Clearview Strep A Exact II Dipstick Respiratory Kit
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Mckesson Medical-Surgi…VAAug 27, 2025