Microgenics Corporation

Complete recall history across all FDA and CPSC categories — 9 total recalls

Microgenics Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Microgenics Corporation

Date Product Reason Class
Oct 1, 2025 Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control,... The firm received complaints from customers reporting vial-to-vial variabilit... Class II
Jan 20, 2022 QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL ... Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target... Class II
Aug 15, 2016 Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribut... A reagent stability issue (still under investigation) causes less separation ... Class II
Jul 25, 2016 DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI ... Some lots of DRI Salicylate Serum Tox Assay negative patient samples are reco... Class II
Oct 20, 2014 MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for ... MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variatio... Class II
Dec 2, 2013 MAS Omni Immune Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMM... Class III
Dec 2, 2013 MAS Omni Immune PRO Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMM... Class III
May 13, 2013 Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Pr... It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and... Class II
Aug 20, 2012 Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integr... In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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