Class IIOngoingZ-2169-2026
Quidel Corporation recalls QuickVue Dipstick Strep A Test
Product has the potential for false positive results
- Streptococcus Spp. All Groups Antigens
- Under Investigation by firm
Quidel CorporationCAMay 20, 2026
Streptococcus Spp. All Groups Antigens recalls
The FDA has posted 6 enforcement recalls of streptococcus spp. all groups antigens devices since 2025, none of them Class I (most serious). Most recent report: May 20, 2026.
Class II: 6
Who is recalling these devices
Latest recalls
View all 6 in the recall browser →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.
- Streptococcus Spp. All Groups Antigens
- No Marketing Application
Altruan GmbHMar 18, 2026
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.
- Streptococcus Spp. All Groups Antigens
- No Marketing Application
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.
- Streptococcus Spp. All Groups Antigens
- No Marketing Application
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.
- Streptococcus Spp. All Groups Antigens
- Under Investigation by firm
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.
- Streptococcus Spp. All Groups Antigens
- Process control
Mckesson Medical-Surgi…VAAug 27, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Antigens, All Groups, Streptococcus Spp.”). Informational only — verify against the FDA before acting.