Test Kits & Diagnostics recalls

2,668 medical device recalls in the test kits & diagnostics category are on file with the FDA, from 2012 to 21 Oct 2026. The leading reason is potency & assay.

Total recalls2,668since 2012

Last 12 months95reported

Class I1004% of total

Ongoing769latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

11Nov '24 7 25 9Feb 8 12 5May 33 6 10Aug 8 10 12Nov 11 5 6Feb 6 4 12May 6 3 17Aug 3 10

Severity split

Class I 100 4%Class II 2,375 89%Class III 193 7%

Why test kits & diagnostics is recalled

Companies

By year

2026723%
20251496%
20241957%
20231556%
20221265%
20211777%
20201706%
20191947%
201831812%
20171596%

Ongoing test kits & diagnostics recalls

769 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled	Microgenics	Potency & Assay	Nationwide
21 Oct 2026Device	CLASS II	The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled	Radiometer Medical ApS	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS I	HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
21 Oct 2026Device	CLASS III	LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Other	Nationwide
21 Oct 2026Device	CLASS I	HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide

All test kits & diagnostics recalls, newest first

2,668 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled	Microgenics	Potency & Assay	Nationwide
21 Oct 2026Device	CLASS II	The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled	Radiometer Medical ApS	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS I	HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
21 Oct 2026Device	CLASS III	LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Other	Nationwide
21 Oct 2026Device	CLASS I	HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	STA Staclot Protein 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	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
19 Aug 2026Device	CLASS II	ProNephro AKI (NGAL) Reagent Kit (100 tests) recalled	Bioporto Diagnostics	Potency & Assay
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	Other	Nationwide
12 Aug 2026Device	CLASS II	FilmArray NGDS Warrior Panel recalled by Biofire Defense	Biofire Defense	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 5000 with IQM2 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	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.