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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 4 of 15

Device	Model / Reference	Registries	Class	Status
CEDIA Multi-Drug Calibrator Primary Cutoffs	1815326	EUDAMEDFDA UDI	IVD General	Active
CEDIA N-Acetylprocainamide Assay (NAPA)	100015	EUDAMEDFDA UDI	IVD General	Active
DRI pH-Detect pH 7.0 Control Kit	100284	EUDAMEDFDA UDI	IVD General	Active
QMS Everolimus Immunoassay	0380005	EUDAMEDFDA UDI	IVD General	Active
DRI THC 60 ng/mL Urine Control	0168	EUDAMEDFDA UDI	IVD General	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	10013877	EUDAMEDFDA UDI	IVD Annex II List B	Active
DRI Propoxyphene Assay	0432	EUDAMEDFDA UDI	IVD General	Active
DRI Ecstasy 750 ng/mL Calibrator	100080	EUDAMEDFDA UDI	IVD General	Active
DRI Cotinine Calibrator Kit	0404	EUDAMEDFDA UDI	IVD General	Active
DRI THC 60 ng/mL Urine Control	1402	EUDAMEDFDA UDI	IVD General	Active
CEDIA Gentamicin II Assay	100016	EUDAMEDFDA UDI	IVD General	Active
QMS Teicoplanin Cal Kit	0374652	EUDAMED	IVD General	Active
DRI Propoxyphene Assay	0433	EUDAMEDFDA UDI	IVD General	Active
DRI Ecstasy 250 ng/mL Calibrator	100082	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Calibrator 500	100252	EUDAMEDFDA UDI	IVD General	Active
MAS Alcohol/Ammonia	10014443	EUDAMEDFDA UDI	IVD General	Active
CEDIA Phencyclidine (PCP) OFT Assay_LC	10021786	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-SP	EUDAMEDFDA UDI	IVD General	Active
QMS Everolimus Cal Kit ROW	0373860	EUDAMED	IVD General	Active
DRI Benzodiazepine Assay	0040	EUDAMEDFDA UDI	IVD General	Active
Phenytoin	5P08-21	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Calibrator 100	10018079	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug Calibrator Secondary Cutoffs	1730517	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HCV Low Control	963001	EUDAMEDFDA UDI	IVD General	Active
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control	OCR-SP	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine Assay	100190	EUDAMEDFDA UDI	IVD General	Active
DRI Drugs of Abuse High Calibrator	0036	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone 100 Controls	100254	EUDAMEDFDA UDI	IVD General	Active
CEDIA LSD Intermediate Calibrator	1732161	EUDAMEDFDA UDI	IVD General	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	LG-S1	EUDAMEDFDA UDI	IVD Annex II List B	Active
MAS CSF Liquid Assayed Cerebral Spinal Fluid	10014444	EUDAMEDFDA UDI	IVD General	Active
CEDIA Methadone Metabolite Assay	1868217	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 3	1594	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine 5 ng/mL Calibrator	100242	EUDAMEDFDA UDI	IVD General	Active
Acrometrix BKV Low Control	960050	EUDAMEDFDA UDI	IVD General	Active
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control	10014179	EUDAMEDFDA UDI	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-4	EUDAMEDFDA UDI	IVD General	Active
DRI Multi-Drug Urine Calibrator 2	1592	EUDAMEDFDA UDI	IVD General	Active
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control	OCR-202	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HCV Mid Control	963002	EUDAMEDFDA UDI	IVD General	Active
DRI THC 50 ng/mL Urine Calibrator	0042	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine Controls	100246	EUDAMEDFDA UDI	IVD General	Active
DRI Drugs of Abuse Low Calibrator	0034	EUDAMEDFDA UDI	IVD General	Active
DRI THC 40 ng/mL Urine Control	0170	EUDAMEDFDA UDI	IVD General	Active
Acrometrix HIV-1 Low Control	964001	EUDAMEDFDA UDI	IVD General	Active
Dri Etg Assay, 68ml	10011297	EUDAMED	IVD General	Active
CEDIA Methamphetamine OFT Negative Calibrator	10014950	EUDAMEDFDA UDI	IVD General	Active
DRI Phencyclidine Assay	0160	EUDAMEDFDA UDI	IVD General	Active
DRI Cannabinoid Assay	0186	EUDAMEDFDA UDI	IVD General	Active
Acrometrix Multi-Analyte Control HIV/HCV/HBV Low	967150	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.