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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 9 of 15

Device	Model / Reference	Registries	Class	Status
DRI Ecstasy 500 ng/mL Calibrator	100081	EUDAMEDFDA UDI	IVD General	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	LIG-101	EUDAMEDFDA UDI	IVD Annex II List B	Active
DRI Methadone Metabolite 150 ng/mL Calibrator	100117	EUDAMEDFDA UDI	IVD General	Active
MAS® UA DipTube Liquid Assayed Urinalysis Control	UAT-MP	EUDAMEDFDA UDI	IVD General	Active
Alinity c Benzodiazepines Reagent Kit	09P5220	EUDAMED	IVD General	Active
CEDIA Multi-Drug Calibrator Primary Cutoffs	1815334	EUDAMEDFDA UDI	IVD General	Active
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control	10014182	EUDAMEDFDA UDI	IVD General	Active
Alinity c DOA MC I Controls	08P6318	EUDAMED	IVD General	Active
DRI Cotinine Assay	0395	EUDAMEDFDA UDI	IVD General	Active
CEDIA Heroin Metabolite (6-AM) Assay	100108	EUDAMEDFDA UDI	IVD General	Active
DRI Barbiturate Assay	0226	EUDAMEDFDA UDI	IVD General	Active
CEDIA DAU THC 50 Control Set	1661078	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HIV-1 High Control	964003	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone 300 Controls	100255	EUDAMEDFDA UDI	IVD General	Active
CEDIA AntibioticTDM Multi-Calibrator	100017	EUDAMEDFDA UDI	IVD General	Active
CEDIA Mycophenolic Acid Assay	10016265	EUDAMEDFDA UDI	IVD General	Active
CEDIA Precision ES - 2.3% Detergent Stock (2 x 5.0 mL)	100032	EUDAMED	IVD General	Active
CEDIA Phenobarbital II Assay	100003	EUDAMEDFDA UDI	IVD General	Active
DRI Phencyclidine Assay	10014673	EUDAMEDFDA UDI	IVD General	Active
Alinity c Cannabinoids Reagent Kit	09P5420	EUDAMED	IVD General	Active
DRI Digoxin Assay	1669	EUDAMEDFDA UDI	IVD General	Active
Alinity c Tox Qual Calibrators	08P6802	EUDAMED	IVD General	Active
DRI Negative Urine Calibrator	1664	EUDAMEDFDA UDI	IVD General	Active
DRI Cotinine Low Control	0460	EUDAMEDFDA UDI	IVD General	Active
QMS Vancomycin Immunoassay	0373589	EUDAMEDFDA UDI	IVD General	Active
MAS PAR TDM Liquid Assayed Therapeutic Drug Control	PTD1-1001	EUDAMEDFDA UDI	IVD General	Active
Alinity c Phencyclidine	09P6620	EUDAMED	IVD General	Active
CEDIA Tobramycin II	100018	EUDAMEDFDA UDI	IVD General	Active
DRI Creatinine-Detect Test	100273	EUDAMED	IVD General	Active
MAS CSF Liquid Assayed Cerebrospinal Fluid Control	CSF-MP	EUDAMEDFDA UDI	IVD General	Active
MAS PAR TDM Liquid Assayed Therapeutic Drug Control	PTD2-2002	EUDAMEDFDA UDI	IVD General	Active
DRI Ethyl Glucuronide 625 ng/mL Control	10012136	EUDAMED	IVD General	Active
MAS Immunology Liquid Assayed Immunology Control	IC-202	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Assay	10016403	EUDAMEDFDA UDI	IVD General	Active
DRI pH 11.5 Control	100281	EUDAMEDFDA UDI	IVD General	Active
DRI Serum Tox Calibrator 3	0967	EUDAMEDFDA UDI	IVD General	Active
MAS Bilirubin Liquid Assayed Bilirubin Control	10014431	EUDAMEDFDA UDI	IVD General	Active
DRI THC 50 ng/mL Urine Calibrator	1398	EUDAMEDFDA UDI	IVD General	Active
DRI QUEST Cannibinoid Assay	10009976	EUDAMEDFDA UDI	IVD General	Active
DRI Amphetamine Assay	0017	EUDAMEDFDA UDI	IVD General	Active
DRI Tricyclics Serum Tox Assay	1128	EUDAMEDFDA UDI	IVD General	Active
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control	OCR-303	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Metabolite 1000 ng/mL Calibrator	100120	EUDAMEDFDA UDI	IVD General	Active
Acrometrix Negative Control	962000A	EUDAMEDFDA UDI	IVD General	Active
DRI T-Uptake Calibrator Kit	0738	EUDAMEDFDA UDI	IVD General	Active
MAS PAR TDM Liquid Assayed Therapeutic Drug Control	PTD-S1	EUDAMEDFDA UDI	IVD General	Active
Alinity c Ecstasy Semiquant Calibrator	09P5802	EUDAMED	IVD General	Active
MAS Immunology Liquid Assayed Immunology Control	IC-V3	EUDAMEDFDA UDI	IVD General	Active
MAS Immunology Liquid Assayed Immunology Control	IC-S1	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 3	1595	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.