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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 10 of 15

Device	Model / Reference	Registries	Class	Status
Alinity c Opiates Assay	09P6520	EUDAMED	IVD General	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	LIG-303	EUDAMEDFDA UDI	IVD Annex II List B	Active
CEDIA Multi-Drug OFT Negative Calibrator	10014954	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Assay	10015632	EUDAMEDFDA UDI	IVD General	Active
DRI 300 mg/dL Alcohol Control	0243	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methadone Metabolite (EDDP) Assay	100096	EUDAMEDFDA UDI	IVD General	Active
DRI THC 125 ng/mL Urine Control	1404	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine Assay	100240	EUDAMEDFDA UDI	IVD General	Active
CEDIA DAU Benzodiazepine	1775561	EUDAMEDFDA UDI	IVD General	Active
CEDIA Negative Calibrator	1557416	EUDAMEDFDA UDI	IVD General	Active
AcroMetrix BB NAT WNV Negative Control	960600	EUDAMEDFDA UDI	IVD General	Active
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control	10014181	EUDAMEDFDA UDI	IVD General	Active
Carbamazepine	5P05-21	EUDAMEDFDA UDI	IVD General	Active
MAS UA Control Liquid Assayed Urinalysis Control	UAB-MP	EUDAMEDFDA UDI	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-6	EUDAMEDFDA UDI	IVD General	Active
CEDIA DAU Opiate	1661248	EUDAMEDFDA UDI	IVD General	Active
DRI Ethyl Alcohol Assay	0038	EUDAMEDFDA UDI	IVD General	Active
DRI Serum Tox Negative Calibrator	0962	EUDAMEDFDA UDI	IVD General	Active
MAS® CardioImmune Ultra Low Control (6 x 3 mL)	CAI-UL	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Assay	0596	EUDAMEDFDA UDI	IVD General	Active
CEDIA Mycophenolic Acid	100276	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control	OIM-202	EUDAMEDFDA UDI	IVD Annex II List B	Active
CEDIA Multi-Drug Optional Cutoff Calibrator	100033	EUDAMEDFDA UDI	IVD General	Active
DRI Serum Tox Calibrator 4	0976	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine 0 ng/mL Calibrator	100241	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug Calibrator Clinical Cutoffs	1730401	EUDAMEDFDA UDI	IVD General	Active
CEDIA Heroin Metabolite (6-AM) Assay	10015213	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug Intermediate Calibrator	1732218	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug OFT Cutoff Calibrator	10014955	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methadone Metabolite (EDDP) Assay	100087	EUDAMEDFDA UDI	IVD General	Active
DRI Thyroxine (T4)	0454	EUDAMEDFDA UDI	IVD General	Active
CEDIA Bupernorphine II 100ng/mL Calibrator	10020802	EUDAMEDFDA UDI	IVD General	Active
CEDIA Amphetamine OFT Assay	10018579	EUDAMEDFDA UDI	IVD General	Active
CEDIA Bupernorphine II Assay	10020849	EUDAMEDFDA UDI	IVD General	Active
QMS Topiramate Calibrators	0374173	EUDAMEDFDA UDI	IVD General	Active
DRI Benzodiazepine Serum Tox Assay	0920	EUDAMEDFDA UDI	IVD General	Active
Acrometrix EBV Low Plasma Control	961230	EUDAMEDFDA UDI	IVD General	Active
DRI THC 200 ng/mL Urine Calibrator	1400	EUDAMEDFDA UDI	IVD General	Active
DRI Serum Tox Calibrator 1	0963	EUDAMEDFDA UDI	IVD General	Active
CEDIA Barbiturate Assay	100084	EUDAMEDFDA UDI	IVD General	Active
Alinity c DOA MC Semiquant Calibrator Kit	08P6303	EUDAMED	IVD General	Active
CEDIA Opiate OFT Assay_LC	10021778	EUDAMEDFDA UDI	IVD General	Active
MAS® T-Marker Liquid Assayed Tumor Marker Control	TUM-303	EUDAMEDFDA UDI	IVD Annex II List B	Active
DRI Methadone Metabolite Assay	100116	EUDAMEDFDA UDI	IVD General	Active
DRI Acetaminophen Serum Tox Calibrator	1091	EUDAMEDFDA UDI	IVD General	Active
DRI Opiate Assay	0136	EUDAMEDFDA UDI	IVD General	Active
QMS® Lidocaine (LIDO) Calibrators	0374678	EUDAMEDFDA UDI	IVD General	Active
CEDIA THC 100 Calibrator	1557530	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Level THC Assay	100091	EUDAMEDFDA UDI	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-1	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.