Microgenics recalls

Microgenics has 11 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 5 Nov 2025. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls11since 2012

Last 12 months1reported

Class I00% of total

Ongoing2latest 5 Nov 2025

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 1 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 73%Class III 3 27%

Why microgenics is recalled

Product types

By year

202519%
202219%
2016218%
2014327%
2013327%
201219%

Ongoing microgenics recalls

2 active

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS II	In Vitro Diagnostic external control recalled by Microgenics	Microgenics	Lead & Heavy Metals	Nationwide
6 Jul 2022Device	CLASS II	QMS Tacrolimus Immunoassay recalled by Microgenics	Microgenics	Potency & Assay	21 states

All microgenics recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS II	In Vitro Diagnostic external control recalled by Microgenics	Microgenics	Lead & Heavy Metals	Nationwide
6 Jul 2022Device	CLASS II	QMS Tacrolimus Immunoassay recalled by Microgenics	Microgenics	Potency & Assay	21 states
12 Oct 2016Device	CLASS II	Thermo Scientific QMS Everolimus Assay recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
5 Oct 2016Device	CLASS II	DRI Salicylate Serum Tox Assay recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
10 Dec 2014Device	CLASS II	MAS CardioImmune XL Cardiac Marker Control recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
2 Jul 2014Device	CLASS III	MAS Omni Immune Controls recalled by Microgenics	Microgenics	Packaging Defects	Nationwide
2 Jul 2014Device	CLASS III	MAS Omni Immune PRO Controls recalled by Microgenics	Microgenics	Packaging Defects	Nationwide
25 Dec 2013Device	CLASS II	Thermo Fisher Scientific/Microgenics Cedia Tobramycin II Assay recalled	Microgenics	Potency & Assay	Nationwide
2 Oct 2013Device	CLASS II	DRI Cocaine Metabolite Assay recalled by Microgenics	Microgenics	Potency & Assay	21 states
3 Jul 2013Device	CLASS II	Thermo Scientific MAS Bilirubin for Siemens recalled by Microgenics	Microgenics	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.