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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 2 of 15

Device	Model / Reference	Registries	Class	Status
ARCHITECT Ethanol 100 Calibrator	3L36-02	EUDAMED	IVD General	Active
ARCHITECT Cannabinoid 75 Control	3L41-14	EUDAMED	IVD General	Active
ARCHITECT Barbiturates	3L38-20	EUDAMED	IVD General	Active
ARCHITECT DOA MC 2 Control	3L42-11	EUDAMED	IVD General	Active
ARCHITECT Opiates 500 Calibrator	3L34-03	EUDAMED	IVD General	Active
DRI Oxycodone Calibrator 300	05178525190	EUDAMED	IVD General	Active
MAS HIV p24 Positive Control	10027481	FDA UDI	Class I	Active
Oral-Eze Sample Extractor	96105-500	FDA UDI	Class II	Active
AcroMetrix BB NAT Negative Control	963600	FDA UDI	Class II	Active
CEDIA T Uptake	100049	FDA UDI	Class II	Active
MAS Diabetes Max-SP (Sample-Pack)	B40000688	FDA UDI	Class I	Active
MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 1	OCRL-101	FDA UDI	Class I	Active
MAS anti-HBs Positive Control	10027482	FDA UDI	Class I	Active
MAS Syphilis Positive Control	10027483	FDA UDI	Class I	Active
MAS OmniCORE Max, Level 1	OCRM-101	FDA UDI	Class I	Active
CEDIA Cocaine Assay	100086	FDA UDI	Class II	Active
AcroMetrix BB NAT HCV Positive Control	963601	FDA UDI	Class II	Active
MAS OmniCORE Max, Level 3	OCRM-303	FDA UDI	Class I	Active
MAS Diabetes Max, Multi-pack	B40000687	FDA UDI	Class I	Active
MAS PTH Control Liquid Assayed PTH Control	PTH-MP	FDA UDI	Class I	Active
MGC Select DAU Control Set	100202	EUDAMEDFDA UDI	Class I	Active
Oral-Eze Collection System	96100-500	FDA UDI	Class II	Active
DRI Salicylate Calibrator Kit	0980	FDA UDI	Class II	Unknown
MAS Omni•IMMUNE PRO Max, Level 2	OPROM-202	FDA UDI	Class I	Active
CEDIA Antibiotic TDM Multi-Cal	08777934 190	FDA UDI	Class II	Active
MAS Omni•IMMUNE PRO Max, Level 3	OPROM-303	FDA UDI	Class I	Active
QMS Plazomicin Immunoassay	10023647	FDA UDI	Class II	Active
MAS UrichemTRAK Liquid Assayed Urine Control	UR-MP	FDA UDI	Class I	Active
Acrometrix TriScreen	960811	FDA UDI	Class I	Active
MAS® ChemTRAK H Liquid Assayed Chemistry Control	CHA-3	FDA UDI	Class I	Active
MAS ChemTRAK H Unassayed Liquid Unassayed Chemistry Control	CHU-3	FDA UDI	Class I	Active
MAS Urinalysis Liquid Urinalysis Control 1	024222	FDA UDI	Class I	Active
CEDIA Amphetamines/Ecstasy Assay	100104	FDA UDI	Class II	Active
MAS SARS-CoV-2 Negative Control	10028306	FDA UDI	Class I	Active
Acrometrix HIV p24	960038	FDA UDI	Class I	Unknown
CEDIA Cyclosporine-PLUS Assay	10016283	FDA UDI	Class II	Active
MAS Omni•IMMUNE Max, Level 3	OIMM-303	FDA UDI	Class I	Active
MAS Omni•IMMUNE Max, Sample Pack	OIMM-SP	FDA UDI	Class I	Active
MAS Omni•IMMUNE Max, Level 2	OIMM-202	FDA UDI	Class I	Active
MAS SARS-CoV-2 IgG Positive Control	10028305	FDA UDI	Class I	Active
QMS Lamotrigine Assay	10017205	FDA UDI	Class II	Active
MAS UA Control Liquid Assayed Urinalysis Control	UAB-115	FDA UDI	Class I	Active
DRI Salicylate Serum Tox Assay	0977	FDA UDI	Class II	Unknown
MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays	10027480-U	FDA UDI	Class I	Active
MAS T-Marker Liquid Assayed Tumor Marker Control	TUM-S1	FDA UDI	Class I	Active
CEDIA Gentamicin II (GENTC)	09026924 190	EUDAMEDFDA UDI	Class II	Active
Acrometrix BB NAT HIV-1 POS. CTRL	963602	FDA UDI	Class II	Active
DRI Ecstasy Plus Assay	10024631	FDA UDI	Class II	Active
Acrometrix GBS Positive Control	960041	FDA UDI	Class I	Unknown
MGC Primary DAU Control Set	100200	EUDAMEDFDA UDI	Class I	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.