Quidel recalls
5 official recalls and safety alerts involving Quidel since 2023-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Quidel or the relevant agency.
- 2026-05-20
USQuidel Corporation recalls QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Product has the potential for false positive results
FDA · DeviceQuidel CorporationUS Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD,…Official notice →- 2025-09-17
- US
Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Dipstick strep A test has potential for false positive results.
FDA · DeviceQuidel CorporationWorldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC,…Official notice → - 2024-05-01
- US
Quidel Corporation recalls QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may…
FDA · DeviceQuidel CorporationUS: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC…Official notice → - 2024-02-21
- US
Quidel Corporation recalls The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect…
One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct…
FDA · DeviceQuidel CorporationUS Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.Official notice → - 2023-04-05
- US
Quidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,…
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.