Is this your brand? Sign in to claim ownership.

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 12 of 15

Device	Model / Reference	Registries	Class	Status
CEDIA Multi-Drug OFT Control Set	10014957	EUDAMEDFDA UDI	IVD General	Active
CEDIA Opiate OFT Assay	10014873	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control	OIM-101	EUDAMEDFDA UDI	IVD Annex II List B	Active
DRI Multi-Drug Urine Calibrator 4	1597	EUDAMEDFDA UDI	IVD General	Active
DRI Cotinine Assay	0394	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methadone Metabolite Assay	10016421	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HBV Low Control	965001	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methamphatemine OFT Assay	10014949	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Level THC Assay	10016433	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 1	1589	EUDAMEDFDA UDI	IVD General	Active
QMS Tobramycin Calibrators	0374116	EUDAMEDFDA UDI	IVD General	Active
CEDIA THC 50 Calibrator	1557513	EUDAMEDFDA UDI	IVD General	Active
QMS Lamotrigine Immunoassay Calibrator Set	0373787	EUDAMEDFDA UDI	IVD General	Active
MAS® ChemTRAK H Liquid Assayed Chemistry Control	CHA-1	EUDAMEDFDA UDI	IVD General	Active
MAS® UrichemTRAK Liquid Assayed Urine Control	10014127	EUDAMEDFDA UDI	IVD General	Active
DRI Opiate Assay	10014601	EUDAMEDFDA UDI	IVD General	Active
Alinity c DOA MC Negative Calibrator Kit	08P6305	EUDAMED	IVD General	Active
QMS Lidocaine Immunoassay	0374686	EUDAMEDFDA UDI	IVD General	Active
CEDIA Cannabinoids OFT Assay_LC	10021737	EUDAMEDFDA UDI	IVD General	Active
DRI Ecstasy 1000 ng/mL Calibrator	100079	EUDAMEDFDA UDI	IVD General	Active
Alinity c Propoxyphene	09P8720	EUDAMED	IVD General	Active
MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control	CAI-XL2	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methamphetamine OFT Assay_LC	10021753	EUDAMEDFDA UDI	IVD General	Active
Acrometrix CT/NG Control	967146	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methadone Assay	100088	EUDAMEDFDA UDI	IVD General	Active
MAS® ChemTRAK H Unassayed Control Sample Pack	CHU-SP	EUDAMEDFDA UDI	IVD General	Active
Urine Dipstick Control	URN5005	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control	OPRO-303	EUDAMEDFDA UDI	IVD Annex II List B	Active
DRI Opiate Assay	0135	EUDAMEDFDA UDI	IVD General	Active
CEDIA Phencyclidine (PCP) Assay	1815784	EUDAMEDFDA UDI	IVD General	Active
CEDIA Amphetamines/Ecstasy Assay	100103	EUDAMEDFDA UDI	IVD General	Active
QMS Everolimus Immunoassay	10015987	EUDAMEDFDA UDI	IVD General	Active
CEDIA THC 25 Calibrator	1557505	EUDAMEDFDA UDI	IVD General	Active
Alinity c Cannabinoids Semiquant 100 Calibrator Kit	09P5402	EUDAMED	IVD General	Active
QMS Amikacin Assay	10017196	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Calibrator 300	100251	EUDAMEDFDA UDI	IVD General	Active
CEDIA Digitoxin Assay	100004	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Calibrator 1000	100253	EUDAMEDFDA UDI	IVD General	Active
CEDIA Barbiturate Assay	10017365	EUDAMEDFDA UDI	IVD General	Active
DRI THC 75 ng/mL Urine Control	0214	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control	OIM-SP	EUDAMEDFDA UDI	IVD Annex II List B	Active
QMS Tacrolimus Immunoassay	10015556	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 2	1591	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Assay	100248	EUDAMEDFDA UDI	IVD General	Active
CEDIA PPX/METD Cutoff Calibrator	1662848	EUDAMEDFDA UDI	IVD General	Active
AcroMetrix HCVRNA+	961242	EUDAMED	IVD General	Active
DRI Methaqualone Assay	0515	EUDAMEDFDA UDI	IVD General	Active
MAS Tox Control Liquid Assayed Toxicology Control	10011608	EUDAMEDFDA UDI	IVD General	Active
DRI Thyroxine (T4) Calibrator Kit	0476	EUDAMEDFDA UDI	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-2	EUDAMEDFDA UDI	IVD General	Active

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.