Quidel Corporation recalls
Every recall we track for Quidel Corporation — 12 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Quidel Corporation peaked in 2024 (3); 12 since 2017. 8% rated “stop using now”.
All FDA recall records for Quidel Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 1 | 0 | 2 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 3 | 0 | 3 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Quidel Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Quidel Corporation recalls
11 shown- Lower riskMedical device
Quidel Corporation recalls QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Quidel recalls QuickVue Dipstick Strep A Test (50T) with potential for false positives. Affected units include specific lot numbers and reference codes. Consumers should check their product details.
QuidelApr 6, 2026 - Lower riskMedical device
Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Quidel recalls specific QuickVue Strep A dipstick tests due to potential false positives. Affected lots may give incorrect results, but no safety risks. Consumers should check their lot numbers.
QuidelJun 17, 2025 - Lower riskMedical device
Quidel Corporation recalls QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Quidel recalls 20-test InflammaDry MMP-9 Test (lot #162620/162748) due to misaligned test line causing false negatives in positive results. Consumers should check UDI for affected units.
QuidelMar 5, 2024 - Lower riskMedical device
Quidel Corporation recalls The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2
Quidel recalls a specific lot of Sofia 2 Flu + SARS Antigen FIA tests with incorrect expiration dates. The kits may expire before the actual shelf life, potentially leading to inaccurate results. Affected units have lot number 709083.
QuidelJan 3, 2024 - Lower riskMedical device
Quidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum,
Quidel recalls MicroVue C1-Inhibitor Plus EIA kits with specific lot numbers for potential low OD values causing test failures. Affected kits may produce inaccurate results.
QuidelFeb 1, 2023 - Lower riskMedical device
Quidel Corporation recalls Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time
Quidel recalls Lyra Direct SARS-CoV-2 Assay due to potential false negatives in high viral load samples when used with certain PCR machines. Affected units may need retesting or alternative methods.
QuidelAug 13, 2021 - Lower riskMedical device
Quidel Corporation recalls Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Quidel recalls Lyra SARS-CoV-2 Assay (M120) reagents with specific lot numbers due to rare false negative results when viral load is high and Ct values drop below 5.
QuidelApr 27, 2021 - Lower riskMedical device
Quidel Corporation recalls QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Quidel recalls Sofia SARS Antigen FIA IVD REF 20374 due to false positive results. Affected units include specific model and lot numbers.
QuidelSep 25, 2020 - Lower riskMedical device
Quidel Corporation recalls Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay
Quidel recalls Sofia SARS Antigen FIA tests that may give false positive results if viral transport media is used. Consumers should test directly from swabs without transport media.
QuidelSep 17, 2020 - Lower riskMedical device
Quidel Corporation recalls Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based
Quidel recalls Sofia 2 Analyzer (Catalog 20299) with serial numbers listed. The device may have calibration errors that cause test failures, especially near assay cutoffs.
QuidelDec 15, 2017 - Stop using nowMedical device
Quidel Corporation recalls InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the
Quidel recalls InflammaDry Sample Collectors with plastic spurs that could cause injury during use. Affected lots 1705405 and 170:1705359. Stop using immediately.
QuidelJun 22, 2017
Quidel Corporation recall questions
How many recalls has Quidel Corporation had?
12 recalls from Quidel Corporation are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Quidel Corporation recall?
Quidel Corporation recalls QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp., dated Apr 6, 2026. Every Quidel Corporation recall is listed on this page, newest first.
What should I do if I have a recalled Quidel Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Quidel Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.