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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 13 of 15

Device	Model / Reference	Registries	Class	Status
MAS UA Control Liquid Assayed Urinalysis Control	UAB-260	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-MP	EUDAMEDFDA UDI	IVD General	Active
QMS Zonisamide Controls	0373373	EUDAMEDFDA UDI	IVD General	Active
MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control	CAI-XL3	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Metabolite 300 ng/mL Calibrator	100118	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methamphetamine OFT Cutoff Calibrator	10014951	EUDAMEDFDA UDI	IVD General	Active
MAS Immunology Liquid Assayed Immunology Control	IC-101	EUDAMEDFDA UDI	IVD General	Active
DRI Benzodiazepine Assay	0039	EUDAMEDFDA UDI	IVD General	Active
Alinity c Tox Controls	08P6810	EUDAMED	IVD General	Active
DRI pH Detect Test	10015654	EUDAMEDFDA UDI	IVD General	Active
DRI THC 100 ng/mL Urine Calibrator	1399	EUDAMEDFDA UDI	IVD General	Active
CEDIA Phencyclidine (PCP) Assay	100172	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Assay	10019766	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control	PRO-202	EUDAMEDFDA UDI	IVD Annex II List B	Active
DRI Negative Alcohol Calibrator	0311	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Assay Control Kit (2 x 10 mL)	10018149	EUDAMEDFDA UDI	IVD General	Active
MAS® ChemTRAK H Liquid Assayed Chemistry Control	CHA-SP	EUDAMEDFDA UDI	IVD General	Active
Alinity c Cannabinoids Control 1 Kit	09P5410	EUDAMED	IVD General	Active
CEDIA Cannabinoids OFT Assay	10014910	EUDAMEDFDA UDI	IVD General	Active
DRI Negative Alcohol Calibrator	1405	EUDAMEDFDA UDI	IVD General	Active
CEDIA Propoxyphene LC	1661523	EUDAMEDFDA UDI	IVD General	Active
DRI Cannabinoid Assay	0185	EUDAMEDFDA UDI	IVD General	Active
DRI Opiate Urine Calibrator 1	1609	EUDAMEDFDA UDI	IVD General	Active
Alinity c Benzodiazepines Qual Calibrator	09P5201	EUDAMED	IVD General	Active
CEDIA Multi-Drug Intermediate Calibrator	1730380	EUDAMEDFDA UDI	IVD General	Active
CEDIA DAU Cocaine	1661230	EUDAMEDFDA UDI	IVD General	Active
CEDIA Cocaine Assay	10016413	EUDAMEDFDA UDI	IVD General	Active
Valproic Acid II	100013	EUDAMEDFDA UDI	IVD General	Active
DRI Amphetamine Assay	10014585	EUDAMEDFDA UDI	IVD General	Active
DRI THC 100 ng/mL Urine Calibrator	0044	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Assay for Synchron Systems	10012653	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 4	1598	EUDAMEDFDA UDI	IVD General	Active
CEDIA Cannabinoids OFT Assay	10018585	EUDAMEDFDA UDI	IVD General	Active
DRI Cocaine Metabolite Assay	10014593	EUDAMEDFDA UDI	IVD General	Active
CEDIA DAU Opiate	100089	EUDAMEDFDA UDI	IVD General	Active
MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control	CAI-XLL	EUDAMEDFDA UDI	IVD General	Active
CEDIA Cocaine OFT Assay	10018590	EUDAMEDFDA UDI	IVD General	Active
Hema-Trol	HYC84669	EUDAMEDFDA UDI	IVD General	Active
MAS® T-Marker Liquid Assayed Tumor Marker Control	TUM-101	EUDAMEDFDA UDI	IVD General	Active
CEDIA Phencyclidine (PCP) OFT Assay	10014888	EUDAMEDFDA UDI	IVD General	Active
CEDIA Heroin Metabolite (6-AM) Cutoff-Calibrator	100031	EUDAMEDFDA UDI	IVD General	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	10013876	EUDAMEDFDA UDI	IVD Annex II List B	Active
CEDIA Gentamicin II Assay (95 tests)	08772525190	EUDAMEDFDA UDI	IVD General	Active
CEDIA Heroin Metabolite (6-AM) Assay	100107	EUDAMEDFDA UDI	IVD General	Active
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control	10014180	EUDAMEDFDA UDI	IVD General	Active
Alinity c TDM Multiconstituent Calibrator	08P7404	EUDAMED	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-L	EUDAMEDFDA UDI	IVD General	Active
CEDIA LSD High Calibrator	1732196	EUDAMEDFDA UDI	IVD General	Active
QMS Lamotrigine Immunoassay	0373795	EUDAMEDFDA UDI	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-5	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.