Roche Diagnostics recalls

Roche Diagnostics has 39 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 24 Jul 2019. The most frequent reason is potency & assay.

Total recalls39since 2017

Last 12 months0reported

Class I13% of total

Ongoing0latest 24 Jul 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 3%Class II 36 92%Class III 2 5%

Why roche diagnostics is recalled

Product types

By year

20191231%
20182154%
2017615%

All roche diagnostics recalls, newest first

39 total

Reported	Class	Recall	Company	Reason	Where
24 Jul 2019Device	CLASS II	The Tina-quant lgA Gen.2 is an immunoturbidimetric assay recalled	Roche Diagnostics	Potency & Assay	AL, IN, KY
10 Jul 2019Device	CLASS III	cobas p 701 post-analytical units recalled by Roche Diagnostics	Roche Diagnostics	Other	Nationwide
10 Jul 2019Device	CLASS III	cobas p 501 post-analytical units recalled by Roche Diagnostics	Roche Diagnostics	Other	Nationwide
29 May 2019Device	CLASS II	Cobas¿ infinity central lab IT solution Material Number recalled	Roche Diagnostics	Device Malfunction	11 states
8 May 2019Device	CLASS II	cobas e 801 immunoassay analyzer recalled by Roche Diagnostics	Roche Diagnostics	Lead & Heavy Metals	26 states
24 Apr 2019Device	CLASS II	Tina-quant IgM Gen.2 recalled by Roche Diagnostics	Roche Diagnostics	Potency & Assay	Nationwide
24 Apr 2019Device	CLASS II	Bilirubin Total Gen.3, Cat recalled by Roche Diagnostics	Roche Diagnostics	Potency & Assay	Nationwide
24 Apr 2019Device	CLASS II	Albumin BCP recalled by Roche Diagnostics	Roche Diagnostics	Device Malfunction	Nationwide
24 Apr 2019Device	CLASS II	Lactate Gen.2 recalled by Roche Diagnostics	Roche Diagnostics	Potency & Assay	Nationwide
17 Apr 2019Device	CLASS II	cobas c 111 with ISE analyzers analyzer used recalled	Roche Diagnostics	Potency & Assay	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.