Quidel Corporation

Reports per year

Source: FDA adverse event reports by year received, 2001–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Coronavirus Antigen Detection Test System.QKP8,626
• Covid-19 Multi-Analyte Antigen DeviceQMN2,471
• Reagents, 2019-Novel Coronavirus Nucleic AcidQJR802
• Antigens, All Groups, Streptococcus Spp.GTY2
• Visual, Pregnancy Hcg, Prescription UseJHI2
• Devices Detecting Influenza A, B, And C Virus AntigensPSZ2
• Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1
• Antisera, All Groups, Streptococcus Spp.GTZ1
• Over-The-Counter Covid-19 Antigen TestQYT1

Recent recalls

• 2026-05-12Open, ClassifiedUnder Investigation by firm

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

  Product has the potential for false positive results

• 2025-09-10Open, ClassifiedUnder Investigation by firm

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

  Dipstick strep A test has potential for false positive results.

• 2024-04-24Open, ClassifiedProcess design

  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 test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

• 2024-04-24Open, ClassifiedProcess design

  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 test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

• 2024-02-14Open, ClassifiedUnder Investigation by firm

  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.

  One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.

• 2023-03-30Open, ClassifiedRelease of Material/Component prior to receiving test results

  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

  Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

• 2021-06-26TerminatedDevice Design

  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 have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.

• 2017-02-22TerminatedMixed-up of materials/components

  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

  Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.

• 2013-02-14TerminatedNonconforming Material/Component

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

  Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.

• 2011-03-01TerminatedPending

  QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842

  The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test cassettes are clearly labeled as H. pylori. Nevertheless, there is a risk that customers may overlook this labeling.