Manufacturer

Microgenics Corporation

9 recalls in our database name Microgenics Corporation as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2025-11-05

Of the 9 recalls from Microgenics Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

HighFDA (Devices)·Z-0415-2026·2025-11-05
Cardiac control material recalled over vial to vial troponin variability
Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.
Product
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1284-2022·2022-07-06
Tacrolimus Calibrator Set Recalled for Inaccurate Immunoassay Quantitation
The QMS Tacrolimus Calibrator Set is recalled because calibrators recovered 82-94% of target values, causing inaccurate (over-quantitated) patient drug test results. This affects healthcare facilities in 20 US states and 9 countries.
Product
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0008-2017·2016-10-12
Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue
Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.
Product
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyz
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2884-2016·2016-10-05
Microgenics Recalls DRI Salicylate Serum Tox Assay Due to Sensitivity Issues
Microgenics Corporation is recalling specific lots of DRI Salicylate Serum Tox Assay kits because negative patient samples are recovering higher than the product's sensitivity claim.
Product
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0501-2015·2014-12-10
Microgenics Recalls MAS CardioImmune XL Cardiac Marker Control Due to Variation
Microgenics Corporation is recalling 2,135 vials of MAS CardioImmune XL Cardiac Marker Control (Lot CXL16011) because the product shows vial-to-vial variation for specific analytes.
Product
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1930-2014·2014-07-02
Microgenics Recalls MAS Omni Immune PRO Controls Due to Labeling Error
Microgenics Corporation is recalling MAS Omni Immune PRO Controls because the package insert failed to reflect the removal of the constituent Inhibin A.
Product
MAS Omni Immune PRO Controls
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1929-2014·2014-07-02
Microgenics Recalls MAS Omni Immune Controls Due to Labeling Error
Microgenics Corporation is recalling MAS Omni Immune Controls because the package insert failed to reflect the removal of the constituent Inhibin A.
Product
MAS Omni Immune Controls
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1563-2013·2013-07-03
Thermo Scientific MAS Bilirubin Recalled for Reduced Stability
Microgenics Corporation is recalling Thermo Scientific MAS Bilirubin test samples because in-house testing confirmed reduced stability of Direct and Total Bilirubin.
Product
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in m
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0379-2013·2012-11-28
Microgenics Recalls Thermo Scientific Omni IMMUNE Immunoassay Controls Due to Stability Issues
Microgenics is recalling Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO controls because internal testing showed reduced stability for CK-MS and Insulin.
Product
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed.
Category
Medical Device
Distribution
Distributed nationwide