PlainRecalls

Quidel Corporation

Compiled from official public sources by the editorial team.

14 recalls on record · Latest: May 20, 2026

Quidel Corporation Recall Insight

Quidel Corporation appears on 14 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.014% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 20, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 14 entries, severity tagging shows 1 critical, 13 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 14 of 14 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (14). The date window on this page runs from Feb 20, 2013 to May 20, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 20, 2026

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

FDA Devices Moderate Sep 17, 2025

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

FDA Devices Moderate May 1, 2024

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests

FDA Devices Moderate May 1, 2024

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

FDA Devices Moderate Feb 21, 2024

The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protei…

FDA Devices Moderate Apr 5, 2023

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing …

FDA Devices Moderate Sep 22, 2021

Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for th…

FDA Devices Critical Jul 7, 2021

Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

FDA Devices Moderate Nov 18, 2020

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

FDA Devices Moderate Oct 28, 2020

Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia a…

FDA Devices Moderate Apr 4, 2018

Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnos…

FDA Devices Moderate Aug 9, 2017

InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detec…

FDA Devices Moderate Mar 1, 2017

Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs i…

FDA Devices Moderate Feb 20, 2013

Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Quidel Corporation with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.