Quidel recalls

Quidel has 14 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 20 May 2026. 6 are still ongoing. 1 was reported in the last 12 months.

Total recalls14since 2013

Last 12 months1reported

Class I17% of total

Ongoing6latest 20 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 1 0 0Nov 0 0 0Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 1 7%Class II 13 93%Class III 0 0%

Why quidel is recalled

Product types

Test Kits & Diagnostics964%
Other Medical Devices536%

By year

202617%
202517%
2024321%
202317%
2021214%
2020214%
201817%
2017214%
201317%

Ongoing quidel recalls

6 active

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	QuickVue Dipstick Strep A Test, 50T recalled by Quidel	Quidel	Other	Nationwide
17 Sep 2025Device	CLASS II	QuickVue: Dipstick Strep A Test: 50T recalled by Quidel	Quidel	Other	Nationwide
1 May 2024Device	CLASS II	InflammaDry MMP-9 Test recalled by Quidel	Quidel	Hidden Drug Ingredients	38 states
1 May 2024Device	CLASS II	InflammaDry MMP-9 Test recalled by Quidel	Quidel	Hidden Drug Ingredients	38 states
21 Feb 2024Device	CLASS II	The Sofia 2 Flu + SARS Antigen FIA employs recalled by Quidel	Quidel	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	MicroVue C1-Inhibitor Plus EIA recalled by Quidel	Quidel	Packaging Defects	OH

All quidel recalls, newest first

14 total

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	QuickVue Dipstick Strep A Test, 50T recalled by Quidel	Quidel	Other	Nationwide
17 Sep 2025Device	CLASS II	QuickVue: Dipstick Strep A Test: 50T recalled by Quidel	Quidel	Other	Nationwide
1 May 2024Device	CLASS II	InflammaDry MMP-9 Test recalled by Quidel	Quidel	Hidden Drug Ingredients	38 states
1 May 2024Device	CLASS II	InflammaDry MMP-9 Test recalled by Quidel	Quidel	Hidden Drug Ingredients	38 states
21 Feb 2024Device	CLASS II	The Sofia 2 Flu + SARS Antigen FIA employs recalled by Quidel	Quidel	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	MicroVue C1-Inhibitor Plus EIA recalled by Quidel	Quidel	Packaging Defects	OH
22 Sep 2021Device	CLASS II	Lyra Direct Sars-CoV-2 Assay Emergency Use Authorization recalled	Quidel	Potency & Assay	Nationwide
7 Jul 2021Device	CLASS I	Lyra Sars-CoV-2 Assay (M120) in vitro diagnostic test reagent recalled	Quidel	Potency & Assay	Nationwide
18 Nov 2020Device	CLASS II	Sofia SARS Antigen FIA IVD recalled by Quidel	Quidel	Other	23 states
28 Oct 2020Device	CLASS II	Sofia Sars Antigen Fia Package Insert The Sofia Sars recalled by Quidel	Quidel	Packaging Defects	Nationwide
4 Apr 2018Device	CLASS II	Sofia 2 Analyzer recalled by Quidel	Quidel	Potency & Assay	CA
9 Aug 2017Device	CLASS II	InflammaDry(R) AN Rps Diagnostic Solution recalled by Quidel	Quidel	Foreign Material	Nationwide
1 Mar 2017Device	CLASS II	Influenza Transport Swab Packages, Reference #20171 recalled by Quidel	Quidel	Packaging Defects	Nationwide
20 Feb 2013Device	CLASS II	Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit) recalled by Quidel	Quidel	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.