FDA recall record · openFDA

Quidel Corporation

6 FDA recalls on record (2023–2026) — 6 device. 6 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There are two windows on the test device, the control line window and the test results window. The line for the test res 2

One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contai 1

Dipstick strep A test has potential for false positive results. 1

Product has the potential for false positive results 1

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Valid 1

Recalls

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. Class II 2026-04-06 QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC Class II 2025-06-17 The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 Class II 2024-01-03 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests Class II 2024-03-05 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests Class II 2024-03-05 MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Cat Class II 2023-02-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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