Recall Register

Quidel Corporation: FDA recalls

FDA enforcement reports name Quidel Corporation as the recalling firm in 13 events. The events have 14 product records. The recalls started from 2012 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

13 events, newest first.

FDA enforcement events of Quidel Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
6 Apr 2026QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.DeviceClass II1Ongoing
17 Jun 2025QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SCDeviceClass II1Ongoing
5 Mar 2024QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 TestsDeviceClass II2Ongoing
3 Jan 2024The 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.DeviceClass II1Ongoing
1 Feb 2023MicroVue 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 aboveDeviceClass II1Ongoing
13 Aug 2021Lyra 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…DeviceClass II1Terminated
27 Apr 2021Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagentDeviceClass I1Terminated
25 Sep 2020QUIDEL Sofia SARS Antigen FIA IVD REF 20374DeviceClass II1Terminated
17 Sep 2020Sofia 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…DeviceClass II1Terminated
15 Dec 2017Sofia 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.DeviceClass II1Terminated
22 Jun 2017InflammaDry(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…DeviceClass II1Terminated
25 Jan 2017Influenza 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 testsDeviceClass II1Terminated
3 Dec 2012Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Quidel Corporation: events for each product type
TypeEvents
Device13
Quidel Corporation: events in each class
ClassEvents
Class II12
Class I1
Share of the events of the firm in Class I
8%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Quidel Corporation, by the year that the recall started. The largest year is 2017, with 3 events.

Official channels

Cite this page

Recall Register. Quidel Corporation: FDA recalls. https://recallregister.com/firm/quidel-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA, OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Quidel Corporation have?
Class II: 12 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Quidel Corporation?
FDA event 98709, which the firm started on 6 Apr 2026. The first product in the record is: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
How many FDA recalls of Quidel Corporation have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.