PlainRecalls

Quidel Corporation

Compiled from official public sources by the publisher.

14 recalls on record · Latest: May 20, 2026

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Agency notice ledger

Federal filing book Quidel Corporation LIGHT-BOOK · SINGLE-AGENCY

#1,119 of 14,151 · 14 notices · 0.013% archive

  • BOOK 14 notices
  • RANK #1,119 of 14,151
  • SHARE 0.013% archive
  • AGENCY FDA Devices (14)
  • CAT medical devices
  • CATS 1 category
  • LATEST May 20, 2026
  • PHOTO Actavis Elizabeth LLC

Nearest notice-volume peer: Actavis Elizabeth LLC (0 notice gap)

Quidel Corporation accounts for about 0.013% of the 104,423-notice archive on 14 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Quidel Corporation sits among 14,151 recalling firms

Quidel Corporation ranks 1,119th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Quidel Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

14 1119th of 14151 higher than 13,008 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Quidel Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Quidel Corporation holds about 0.013% of archive notices alongside 14 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
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 Coated Strips, REF: 4634, with an ID number of 2200 or above
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 the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
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 and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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 diagnostic assays . Sofia 2 is intended for professional and laboratory use.
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 detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
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 in dry transport tubes are intended for use with influenza tests
FDA Devices Moderate Feb 20, 2013

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

Quidel Corporation holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (14 here — thin-book).

Actavis Elizabeth LLC 14 Allergan Sales, LLC 14 American Contract Systems 14 Aurolife Pharma, LLC 14 B&g Foods North America, Inc 14

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

American Contract Systems 14 Bd Switzerland Sarl 14 Biomet Spine, LLC 14 Cardiac Assist, Inc 14

Frequently Asked Questions

How many federal recall notices name Quidel Corporation? ▼
PlainRecalls indexes 14 distinct federal recall events naming Quidel Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Quidel Corporation sit among other recalling firms? ▼
Quidel Corporation ranks #1,119 of 14,151 by distinct recall-event count among 14,151 firms in this archive (92nd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Quidel Corporation's notices? ▼
FDA Devices accounts for 14 of this firm's 14 indexed notices.
What product category dominates Quidel Corporation's filing book? ▼
Filings for Quidel Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Quidel Corporation: 14 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Quidel Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026