Quidel Corporation

Complete recall history across all FDA and CPSC categories — 13 total recalls

Quidel Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (13)

FDA medical device enforcement actions by Quidel Corporation

Date Product Reason Class
Jun 17, 2025 QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, ... Dipstick strep A test has potential for false positive results. Class II
Mar 5, 2024 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests There are two windows on the test device, the control line window and the tes... Class II
Mar 5, 2024 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 tes... Class II
Jan 3, 2024 The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with ... Class II
Feb 1, 2023 MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhi... Kits with affected microtiter plates have the potential to produce low OD val... Class II
Aug 13, 2021 Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The ... Revised Instructions for Use: Potential for specimens from patients with high... Class II
Apr 27, 2021 Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent In rare situations patients infected with high viral load of SARS CoV 2 may h... Class I
Sep 25, 2020 QUIDEL Sofia SARS Antigen FIA IVD REF 20374 Due to false positive results. Class II
Sep 17, 2020 Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lat... Instructions for use in the package insert for SARS Antigen FIA test were upd... Class II
Dec 15, 2017 Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer in... The calibration for the affected batch of analyzers was incorrectly set durin... Class II
Jun 22, 2017 InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) ... In-house testing revealed the presence of plastic spurs at the tips of some S... Class II
Jan 25, 2017 Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packa... Quidel Corporation is recalling Influenza Transport Swab Packages because it ... Class II
Dec 3, 2012 Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnos... Quidel Corporation has initiated a voluntary recall of specific lots of the S... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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