Roche Diagnostics Operations recalls

Roche Diagnostics Operations has 127 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 11 Mar 2026. 14 are still ongoing. 2 were reported in the last 12 months.

Total recalls127since 2012

Last 12 months2reported

Class I00% of total

Ongoing14latest 11 Mar 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 121 95%Class III 6 5%

Why roche diagnostics operations is recalled

Product types

By year

202622%
202422%
202322%
202211%
2021129%
2020108%
20191512%
201722%
20162620%
20153024%

Ongoing roche diagnostics operations recalls

14 active

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	cobas pro integrated solutions recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
14 Jan 2026Device	CLASS II	The Elecsys Anti-TSHR immunoassay is a three-step recalled	Roche Diagnostics Operations	Particulate Matter	Nationwide
27 Nov 2024Device	CLASS II	cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled	Roche Diagnostics Operations	Potency & Assay	8 states
2 Oct 2024Device	CLASS II	Creatine Kinase (CK) used on cobas c 311/501/502 recalled	Roche Diagnostics Operations	Potency & Assay	Nationwide
29 Nov 2023Device	CLASS II	Tina-quant D-Dimer Test System recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
18 Jan 2023Device	CLASS II	cobas infinity central lab, Material Number recalled	Roche Diagnostics Operations	Device Malfunction	Nationwide

All roche diagnostics operations recalls, newest first

127 total

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	cobas pro integrated solutions recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
14 Jan 2026Device	CLASS II	The Elecsys Anti-TSHR immunoassay is a three-step recalled	Roche Diagnostics Operations	Particulate Matter	Nationwide
27 Nov 2024Device	CLASS II	cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled	Roche Diagnostics Operations	Potency & Assay	8 states
2 Oct 2024Device	CLASS II	Creatine Kinase (CK) used on cobas c 311/501/502 recalled	Roche Diagnostics Operations	Potency & Assay	Nationwide
29 Nov 2023Device	CLASS II	Tina-quant D-Dimer Test System recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
18 Jan 2023Device	CLASS II	cobas infinity central lab, Material Number recalled	Roche Diagnostics Operations	Device Malfunction	Nationwide
17 Aug 2022Device	CLASS II	cobas e801 Immunoassay Analyzer recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
24 Nov 2021Device	CLASS II	Cobas u 601 urinalysis test system recalled	Roche Diagnostics Operations	Other	Nationwide
22 Sep 2021Device	CLASS II	cobas infinity central lab running recalled	Roche Diagnostics Operations	Device Malfunction	Nationwide
2 Jun 2021Device	CLASS II	Iron Gen 2: Roche Cobas Integra Analyzer, Reagent Cassettes recalled	Roche Diagnostics Operations	Potency & Assay	Nationwide
26 May 2021Device	CLASS II	Elecsys Troponin I Immunoassay recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
26 May 2021Device	CLASS II	Elecsys Troponin I STAT Immunoassay recalled	Roche Diagnostics Operations	Potency & Assay	Nationwide
17 Feb 2021Device	CLASS II	9180 Electrolyte Analyzer recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Device Malfunction	Nationwide
27 Jan 2021Device	CLASS II	A calculator/data processing module recalled	Roche Diagnostics Operations	Device Malfunction	Nationwide
13 Jan 2021Device	CLASS II	CoaguChek XS Prof (Professional) Meters- IVD professional recalled	Roche Diagnostics Operations	Other	Nationwide
13 Jan 2021Device	CLASS II	CoaguChek XS PST Meters- IVD recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Other	Nationwide
6 Jan 2021Device	CLASS II	Roche cobas 8000 modular analyzer series (i.e. recalled	Roche Diagnostics Operations	Other	Nationwide
6 Jan 2021Device	CLASS II	Roche cobas pro integrated solutions (cobas pro ISE recalled	Roche Diagnostics Operations	Other	Nationwide
6 Jan 2021Device	CLASS II	cobas pro integrated solutions -cobas c 503, Analyzer recalled	Roche Diagnostics Operations	Labeling Errors	4 states
23 Dec 2020Device	CLASS II	Tina-quant C-Reactive Protein Gen.3 recalled	Roche Diagnostics Operations	Other	Nationwide
25 Nov 2020Device	CLASS II	cobas infinity central lab/cobas infinity core license recalled	Roche Diagnostics Operations	Device Malfunction	Nationwide
21 Oct 2020Device	CLASS III	Tina-quant Complement C4 ver.2 recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Other	Nationwide
21 Oct 2020Device	CLASS III	Albumin Gen.2 recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Other	Nationwide
14 Oct 2020Device	CLASS II	BenchMark Ultra Advanced Staining System recalled	Roche Diagnostics Operations	Packaging Defects	Nationwide
14 Oct 2020Device	CLASS II	Discovery Ultra Advanced Staining System recalled	Roche Diagnostics Operations	Packaging Defects	Nationwide
23 Sep 2020Device	CLASS II	Elecsys Anti-TPO Assay on cobas e analyzers recalled	Roche Diagnostics Operations	Potency & Assay	Nationwide
11 Mar 2020Device	CLASS II	Elecsys CA recalled by Roche Diagnostics Operations	Roche Diagnostics Operations	Potency & Assay	Nationwide
19 Feb 2020Device	CLASS II	cobas infinity core, Material No. recalled	Roche Diagnostics Operations	Device Malfunction	19 states
5 Feb 2020Device	CLASS II	Cobas infinity central lab / cobas infinity core license recalled	Roche Diagnostics Operations	Device Malfunction	Nationwide
25 Dec 2019Device	CLASS II	Roche Homocysteine-In vitro test recalled	Roche Diagnostics Operations	Device Malfunction	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.