Medical DeviceMay 20, 2026
Quidel QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus recall — FDA Z-2169-2026
Product has the potential for false positive results
Class IIFDA: OngoingQuidel Corporation
Recall history in this database
Classification mix: Class II: 9, Class I: 1.
Medical DeviceSep 17, 2025
Quidel QuickVue: Dipstick Strep A Test: 50T, REF: 20108 recall — FDA Z-2545-2025
Dipstick strep A test has potential for false positive results.
Class IIFDA: OngoingQuidel Corporation
Medical DeviceMay 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests recall — FDA Z-1637-2024
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,…
Class IIFDA: OngoingQuidel Corporation
Medical DeviceMay 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests recall — FDA Z-1636-2024
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,…
Class IIFDA: OngoingQuidel Corporation
Medical DeviceFeb 21, 2024
Quidel The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a recall — FDA Z-1086-2024
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,…
Class IIFDA: OngoingQuidel Corporation
Medical DeviceApr 5, 2023
Quidel MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor recall — FDA Z-1308-2023
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.
Class IIFDA: OngoingQuidel Corporation
Medical DeviceSep 22, 2021
Quidel Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124 recall — FDA Z-2477-2021
Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a…
Class IIFDA: TerminatedQuidel Corporation
Medical DeviceJul 7, 2021
Quidel Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent recall — FDA Z-1928-2021
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…
Class IFDA: TerminatedQuidel Corporation
Medical DeviceOct 28, 2020
Quidel Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow recall — FDA Z-0124-2021
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral…
Class IIFDA: TerminatedQuidel Corporation
Medical DeviceApr 4, 2018
Quidel Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be recall — FDA Z-1183-2018
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e…
Class IIFDA: TerminatedQuidel Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Quidel Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.