Test Kits & Diagnostics recalls

2,656 medical device recalls in the test kits & diagnostics category are on file with the FDA, from 2012 to 9 Sep 2026. The leading reason is potency & assay.

Total recalls2,656since 2012

Last 12 months93reported

Class I984% of total

Ongoing757latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

27Oct '24 11 7 25Jan '25 9 8 12Apr 5 33 6Jul 10 8 10Oct 12 11 5Jan '26 6 6 4Apr 12 6 3Jul 17 1

Severity split

Class I 98 4%Class II 2,366 89%Class III 192 7%

Why test kits & diagnostics is recalled

Companies

By year

2026602%
20251496%
20241957%
20231556%
20221265%
20211777%
20201706%
20191947%
201831812%
20171596%

Ongoing test kits & diagnostics recalls

757 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
19 Aug 2026Device	CLASS II	ProNephro AKI (NGAL) Reagent Kit (100 tests) recalled	Bioporto Diagnostics A/S	Lead & Heavy Metals

All test kits & diagnostics recalls, newest first

2,656 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
19 Aug 2026Device	CLASS II	ProNephro AKI (NGAL) Reagent Kit (100 tests) recalled	Bioporto Diagnostics A/S	Lead & Heavy Metals
19 Aug 2026Device	CLASS II	Thermo Fisher Diagnostics Neisseria meningitidis Gp C/VL recalled	Remel Europe	Other	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit Disopyramide Assay Enzyme Immunoassay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	HardyDisk AST Cefiderocol 30¿g (FDC30) recalled by Hardy Diagnostics	Hardy Diagnostics	Lead & Heavy Metals	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.