Quidel Corporation: Antigens, All Groups, Streptococcus Spp.
Recall Summary Quidel Corporation is recalling QuickVue Dipstick Strep A Test kits (50T, REF 20108) because the tests may produce false positive results, meaning they could indicate a strep infection when one is not actually present. The product was distributed nationwide. This is a Class I recall, which indicates a serious health hazard.
- Recalling firm
- Quidel Corporation
- Product
- QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- Reason
- Product has the potential for false positive results
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6420c978-b514-45ce-9e01-4b0afc17356b