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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 3 of 15

Device	Model / Reference	Registries	Class	Status
Oral-Eze Collection System	96100-050	FDA UDI	Class II	Active
Acrometrix MRSA Positive Control	960091	FDA UDI	Class I	Unknown
CEDIA Opiate Assay	10016429	EUDAMEDFDA UDI	Class II	Active
MAS OmniCORE Max, Level 2	OCRM-202	FDA UDI	Class I	Active
MAS Omni•IMMUNE PRO Max, Level 1	OPROM-101	FDA UDI	Class I	Active
MGC Clinical DAU Control Set	100201	FDA UDI	Class I	Active
Oral-Eze Sample Extractor	96105-050	FDA UDI	Class II	Active
QMS Plazomicin Immunoassay Control	10023697	FDA UDI	Class I	Active
CEDIA Phenytoin II Assay	100002	FDA UDI	Class II	Active
Acrometrix BB NAT HBV Positive Control	963603	FDA UDI	Class I	Active
CEDIA Opiate OFT Assay	10018600	FDA UDI	Class II	Active
OXY DRI Oxycodone	09026916 190	EUDAMEDFDA UDI	Class II	Active
AcroMetrix Oncology Hotspot Control	969056	FDA UDI	Class I	Active
Acrometrix AntiHBs	960855	FDA UDI	Class I	Unknown
OXY Oxycodone	08321248 190	EUDAMEDFDA UDI	Class II	Active
MAS Omni Infectious BSI Positive Control Panel	10027480	FDA UDI	Class I	Active
MAS Omni-Core II Liquid Assayed Integrated Chemistry Control Sample Pack	OCRL-SP	FDA UDI	Class I	Active
CEDIA Opiate 2K Assay	100099	FDA UDI	Class II	Active
CEDIA Negative Calibrator	1661388	FDA UDI	Class II	Active
QMS Plazomicin Immunoassay Calibrator	10023684	FDA UDI	Class II	Active
CEDIA LSD Assay	1732137	EUDAMEDFDA UDI	Class II	Active
MAS anti-HBs Positive Control – For use with Siemens Assays	10027482-U	FDA UDI	Class I	Active
DRI MDA Control	10024435	FDA UDI	Class I	Active
MAS Omni•IMMUNE Max, Level 1	OIMM-101	FDA UDI	Class I	Active
CEDIA DAU Barbiturate Assay	1661213	FDA UDI	Class II	Active
MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 2	OCRL-202	FDA UDI	Class I	Active
Acrometrix MSSA Positive Control	960025	FDA UDI	Class I	Unknown
MAS OmniCORE Max, Sample Pack	OCRM-SP	FDA UDI	Class I	Active
MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 3	OCRL-303	FDA UDI	Class I	Active
MAS T-Marker Liquid Assayed Tumor Marker Control	TUM-202	FDA UDI	Class I	Active
MAS Omni•IMMUNE PRO Max, Sample Pack	OPROM-SP	FDA UDI	Class I	Active
Acrometrix Syphilis	969035	FDA UDI	Class I	Unknown
MAS Infectious Negative Control	10027484	FDA UDI	Class I	Active
DRI pH Calibrator Set	100283	EUDAMEDFDA UDI	IVD General	Active
CEDIA Heroin Metabolite (6-AM) High Calibrator	100034	EUDAMEDFDA UDI	IVD General	Active
CEDIA THC 75 Calibrator	1557521	EUDAMEDFDA UDI	IVD General	Active
DRI Opiate Urine Calibrator 3	1610	EUDAMEDFDA UDI	IVD General	Active
DRI 100 mg/dL Alcohol Calibrator	1406	EUDAMEDFDA UDI	IVD General	Active
AcroMetrix Blue	969032	EUDAMED	IVD General	Active
CEDIA Bupernorphine II 10ng/mL Calibrator	10020799	EUDAMEDFDA UDI	IVD General	Active
DRI Cocaine Metabolite Assay	0056	EUDAMEDFDA UDI	IVD General	Active
AcroMetrix HIVRNA+	961240	EUDAMED	IVD General	Active
Alinity c Tox SemiQuant Calibrators	08P6801	EUDAMED	IVD General	Active
QMS Amikacin Immunoassay	0373910	EUDAMEDFDA UDI	IVD General	Active
QMS Topiramate Immunoassay	0374140	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-202	EUDAMEDFDA UDI	IVD General	Active
QMS Everolimus Reagent ROW	0373852	EUDAMED	IVD General	Active
Acrometrix HCV High Control	963003	EUDAMEDFDA UDI	IVD General	Active
08p5520	08P5520	EUDAMED	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-MP	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.