Test Kits & Diagnostics recalls

2,658 medical device recalls in the test kits & diagnostics category are on file with the FDA, from 2012 to 30 Sep 2026. The leading reason is potency & assay.

Total recalls2,658since 2012

Last 12 months92reported

Class I984% of total

Ongoing759latest 30 Sep 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 0

Severity split

Class I 98 4%Class II 2,368 89%Class III 192 7%

Why test kits & diagnostics is recalled

Companies

By year

2026622%
20251496%
20241957%
20231556%
20221265%
20211777%
20201706%
20191947%
201831812%
20171596%

Ongoing test kits & diagnostics recalls

759 active

Reported	Class	Recall	Company	Reason	Where
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

All test kits & diagnostics recalls, newest first

2,658 total

Reported	Class	Recall	Company	Reason	Where
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
22 Jul 2026Device	CLASS II	ST Aia-Pack Testosterone, IN Vitro Diagnostic Use Only recalled	Tosoh Bioscience	Potency & Assay	Nationwide
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
15 Jul 2026Device	CLASS II	GSP Neonatal GALT Kit recalled by Wallac Oy	Wallac OY	Potency & Assay	Nationwide
17 Jun 2026Device	CLASS II	Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Jun 2026Device	CLASS II	Exent Analyser recalled by The Binding Site Group	The Binding Site Group	Potency & Assay	Nationwide
10 Jun 2026Device	CLASS II	EndoStitch" Polysorb Single Use Loading Unit recalled by Covidien	Covidien	Sterility	Nationwide
10 Jun 2026Device	CLASS II	Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM recalled	Covidien	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	Mon-a-Therm General Purpose Temperature Probe recalled by Covidien	Covidien	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	Mon-a-Therm general purpose temperature probe size recalled by Covidien	Covidien	Temperature Abuse	Nationwide
20 May 2026Device	CLASS II	Zymutest Hia IgG, in vitro diagnostic Elisa kit recalled	Aniara Diagnostica	Packaging Defects	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.