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 8 of 15

Device	Model / Reference	Registries	Class	Status
QMS Zonisamide Immunoassay	0373571	EUDAMEDFDA UDI	IVD General	Active
DRI Cotinine Assay	10018516	EUDAMEDFDA UDI	IVD General	Active
DRI Propoxyphene Assay	10018510	EUDAMEDFDA UDI	IVD General	Active
MAS UA Control Liquid Assayed Urinalysis Control	UAB-160	EUDAMEDFDA UDI	IVD General	Active
DRI Phencyclidine Assay	0161	EUDAMEDFDA UDI	IVD General	Active
QMS Gentamicin Immunoassay (Calibrator)	0373902	EUDAMEDFDA UDI	IVD General	Active
Alinity c Carbamazepine Reagent Kit	08P5820	EUDAMED	IVD General	Active
DRI Hydrocodone Calibrator 300	10018080	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 1	1588	EUDAMEDFDA UDI	IVD General	Active
MAS Alcohol/Ammonia	AAC-MP	EUDAMEDFDA UDI	IVD General	Active
DRI Acetaminophen Serum Tox Assay	1086	EUDAMEDFDA UDI	IVD General	Active
CEDIA Cyclosporine PLUS High Range Calibrators (450/2000)	100012	EUDAMEDFDA UDI	IVD General	Active
QMS Gentamicin Assay	10017107	EUDAMEDFDA UDI	IVD General	Active
DRI T-Uptake (EIA Assay)	0723	EUDAMEDFDA UDI	IVD General	Active
CEDIA Carbamazepine II	100006	EUDAMEDFDA UDI	IVD General	Active
CEDIA THC 150 Calibrator	1557548	EUDAMEDFDA UDI	IVD General	Active
QMS Everolimus Reagent	0380000	EUDAMEDFDA UDI	IVD General	Active
CEDIA Phencyclidine (PCP) Assay	100173	EUDAMEDFDA UDI	IVD General	Active
CEDIA® THC OFT Controls Kit	10014925	EUDAMEDFDA UDI	IVD General	Active
QMS Tobramycin Assay	10017109	EUDAMEDFDA UDI	IVD General	Active
Alinity c Tricyclic Antidepressants	09P9120	EUDAMED	IVD General	Active
CEDIA CsA PLUS Assay	100147	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Level THC Assay	1661256	EUDAMEDFDA UDI	IVD General	Active
Alinity c Methadone	09P6420	EUDAMED	IVD General	Active
Alinity c Tobramycin Reagent Kit	09P9020	EUDAMED	IVD General	Active
DRI Methadone Assay	0597	EUDAMEDFDA UDI	IVD General	Active
DRI Thyroxine (T4)	10013070	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HIV-1 Mid Control	964002	EUDAMEDFDA UDI	IVD General	Active
DRI pH 3.6 Control	100282	EUDAMEDFDA UDI	IVD General	Active
DRI Ethyl Alcohol Assay	10016397	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug Calibrator Secondary Cutoffs	1730428	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Metabolite Assay	100115	EUDAMEDFDA UDI	IVD General	Active
MAS® Bilirubin Liquid Assayed Bilirubin Control	BC102	EUDAMEDFDA UDI	IVD General	Active
Theophylline	5P06-21	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control	OPRO-101	EUDAMEDFDA UDI	IVD Annex II List B	Active
MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control	100280	EUDAMEDFDA UDI	IVD General	Active
MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control	100278	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine 20 ng/mL Calibrator	100243	EUDAMEDFDA UDI	IVD General	Active
Alinity c Cannabinoids Qual Calibrator Kit	09P5401	EUDAMED	IVD General	Active
Acrometrix BKV High Control	960051	EUDAMEDFDA UDI	IVD General	Active
Alinity c DOA MC Qual Low Calibrator Kit 1	08P6301	EUDAMED	IVD General	Active
CEDIA Cocaine OFT Assay LC	10021745	EUDAMEDFDA UDI	IVD General	Active
Alinity c Barbiturates	09P5120	EUDAMED	IVD General	Active
CEDIA Cardiac TDM Multi-Calibrators	100001	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methadone Assay	SKU	EUDAMEDFDA UDI	IVD General	Active
Alinity c Benzodiazepines SemiQuant Calibrator	09P5202	EUDAMED	IVD General	Active
CEDIA THC OFT Cutoff Calibrator	10014923	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Calibrator 1000	10018082	EUDAMEDFDA UDI	IVD General	Active
QMS Tacrolimus Calibrators	10015573	EUDAMEDFDA UDI	IVD General	Active
MAS PAR TDM Liquid Assayed Therapeutic Drug Control	PTD3-3003	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.