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Microgenics Corporation

United States·US-MF-000030375

Last updated September 17, 2026

Information

Country: United States
Address: 46500 , Kato Road, Fremont, United States
Website: www.thermofisher.com/diagnostics
This website did not respond in time when we last checked. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 001-510-979-5000
PRRC Contact: Mark Brandes
EUDAMED SRN: US-MF-000030375
FDA FEI Number: 3010939897
DUNS Number: —

Catalogue (706)

Page 11 of 15

Device	Model / Reference	Registries	Class	Status
MAS Bilirubin Liquid Assayed Bilirubin Control	10014432	EUDAMEDFDA UDI	IVD General	Active
QMS Amikacin Immunossay Calibrator Set	0374157	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine Assay	10015658	EUDAMEDFDA UDI	IVD General	Active
QMS Topiramate Control	0374181	EUDAMEDFDA UDI	IVD General	Active
DRI 100 mg/dL Alcohol Calibrator	0241	EUDAMEDFDA UDI	IVD General	Active
MAS Bilirubin Liquid Assayed Bilirubin Control	10014430	EUDAMEDFDA UDI	IVD General	Active
MAS Urinalysis Liquid Urinalysis Control 1	024225	EUDAMEDFDA UDI	IVD General	Active
CEDIA Amphetamines/Ecstasy	100040	EUDAMEDFDA UDI	IVD General	Active
QMS Vancomycin Immunoassay	10017224	EUDAMEDFDA UDI	IVD General	Active
MAS Diabetes Liquid Assayed Diabetes Control	DBCL-V	EUDAMEDFDA UDI	IVD General	Active
QMS Vancomycin Immunoassay Calibrator	0373597	EUDAMEDFDA UDI	IVD General	Active
DRI Methaqualone Assay	0514	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Assay	10018054	EUDAMEDFDA UDI	IVD General	Active
CEDIA Heroin Metabolite (6-AM) Assay	100186	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Metabolite 2000 ng/mL Calibrator	100122	EUDAMEDFDA UDI	IVD General	Active
Hema-Trol	HYC84666	EUDAMEDFDA UDI	IVD General	Active
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control	OCR-101	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-101	EUDAMEDFDA UDI	IVD General	Active
CEDIA Amphetamine OFT Assay_LC	10021729	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Level THC Assay	100100	EUDAMEDFDA UDI	IVD General	Active
DRI THC 40 ng/mL Urine Control	1401	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HBV Mid Control	965002	EUDAMEDFDA UDI	IVD General	Active
DRI THC 20 ng/mL Urine Calibrator	1397	EUDAMEDFDA UDI	IVD General	Active
CEDIA Cocaine Assay	100095	EUDAMEDFDA UDI	IVD General	Active
Alinity c Ecstasy Reagent Kit	09P5820	EUDAMED	IVD General	Active
Alinity c DOA MC III Controls	08P6312	EUDAMED	IVD General	Active
CEDIA Bupernorphine II Assay	10020850	EUDAMEDFDA UDI	IVD General	Active
QMS Lamotrigine Immunoassay (Control)	0374090	EUDAMEDFDA UDI	IVD General	Active
Alinity c DOA MC II Controls	08P6311	EUDAMED	IVD General	Active
DRI Oxycodone Assay	100249	EUDAMEDFDA UDI	IVD General	Active
MAS ChemTrak H Liquid Assayed Chemistry Control	10014150	EUDAMEDFDA UDI	IVD General	Active
CEDIA PPX/METD Intermediate Calibrator	1662856	EUDAMEDFDA UDI	IVD General	Active
DRI Benzodiazepine Assay	10015644	EUDAMEDFDA UDI	IVD General	Active
CEDIA Propoxyphene Assay	100171	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control	OPRO-SP	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine 50 ng/mL Calibrator	100244	EUDAMEDFDA UDI	IVD General	Active
Acrometrix EBV High Plasma Control	961231	EUDAMEDFDA UDI	IVD General	Active
DRI 50 mg/dL Alcohol Control	0239	EUDAMEDFDA UDI	IVD General	Active
CEDIA Bupernorphine II 20ng/mL Calibrator	10020800	EUDAMEDFDA UDI	IVD General	Active
DRI Negative Urine Calibrator	1388	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Assay	10018053	EUDAMEDFDA UDI	IVD General	Active
CEDUA DAU Opiate 2K	1815296	EUDAMEDFDA UDI	IVD General	Active
DRI Ethyl Alcohol Assay	0037	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HBV High Control	965003	EUDAMEDFDA UDI	IVD General	Active
DRI Ecstasy Assay	10014681	EUDAMEDFDA UDI	IVD General	Active
QMS Quinidine Immunoassay	0373936	EUDAMEDFDA UDI	IVD General	Active
MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control	CAI-XL4	EUDAMEDFDA UDI	IVD General	Active
Hema-Trol	HYC84668	EUDAMEDFDA UDI	IVD General	Active
MAS® Bilirubin Liquid Assayed Bilirubin Control	BC-S1	EUDAMEDFDA UDI	IVD General	Active
DRI pH Detect Test	100054	EUDAMEDFDA UDI	IVD General	Active

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 1, 2025	Z-0415-2026	—	open, classified	The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
Jan 20, 2022	Z-1284-2022	—	open, classified	Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.
Aug 15, 2016	Z-0008-2017	—	terminated	A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range sub-therapeutic, therapeutic, and supra-therapeutic could be affected.
Jul 25, 2016	Z-2884-2016	—	terminated	Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Oct 20, 2014	Z-0501-2015	—	terminated	MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
Dec 2, 2013	Z-1930-2014	—	terminated	The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
Dec 2, 2013	Z-1929-2014	—	terminated	The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
Oct 16, 2013	Z-0513-2014	—	terminated	Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.
Jul 23, 2013	Z-2267-2013	—	terminated	Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
May 13, 2013	Z-1563-2013	—	terminated	It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.
Aug 20, 2012	Z-0379-2013	—	terminated	In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Dec 14, 2011	Z-0637-2012	—	terminated	Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
Nov 11, 2011	Z-0773-2012	—	terminated	Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range.
Jun 8, 2011	Z-0297-2012	—	terminated	Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.