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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 14 of 15

Device	Model / Reference	Registries	Class	Status
CEDIA Methadone Assay	1730916	EUDAMEDFDA UDI	IVD General	Active
DRI Hydrocodone Calibrator 500	10018081	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug High Calibrator	1730398	EUDAMEDFDA UDI	IVD General	Active
QMS Teicoplanin Ctrl Kit	0374660	EUDAMED	IVD General	Active
DRI Creatinine-Detect Test	100274	EUDAMED	IVD General	Active
CEDIA T4 Assay	100050	EUDAMEDFDA UDI	IVD General	Active
TDM Multiconstituent Calibrator	5P04-21	EUDAMEDFDA UDI	IVD General	Active
CEDIA Amphetamine/Ecstasy Assay	10016417	EUDAMEDFDA UDI	IVD General	Active
Alinity c Ecstasy Qual Calibrator Kit	09P5801	EUDAMED	IVD General	Active
DRI pH-Detect 10.0 Control Kit	100285	EUDAMEDFDA UDI	IVD General	Active
QMS Topiramate Assay	10017218	EUDAMEDFDA UDI	IVD General	Active
DRI Digoxin Assay	1669-A	EUDAMEDFDA UDI	IVD General	Active
CEDIA Core TDM Multi-Calibrators	100007	EUDAMEDFDA UDI	IVD General	Active
Alinity c Cannabinoids Semiquant 200 Calibrator Kit	09P5403	EUDAMED	IVD General	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	10013878	EUDAMEDFDA UDI	IVD Annex II List B	Active
MAS Immunology Liquid Assayed Immunology Control	IC-V1	EUDAMEDFDA UDI	IVD General	Active
CEDIA Multi-Drug High Calibrator	1732226	EUDAMEDFDA UDI	IVD General	Active
MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control	100279	EUDAMEDFDA UDI	IVD General	Active
CEDIA Benzodiazepine Assay	100085	EUDAMEDFDA UDI	IVD General	Active
MAS® ChemTRAK H Unassayed Liquid Unassayed Chemistry Control	CHU-2	EUDAMEDFDA UDI	IVD General	Active
CEDIA Speciality Control Set	1815440	EUDAMEDFDA UDI	IVD General	Active
Alinity c Opiates Semiquant Calibrator Kit	09P6502	EUDAMED	IVD General	Active
DRI Barbiturate Serum Tox Assay	0911	EUDAMEDFDA UDI	IVD General	Active
AcroMetrix NATBBV- Control	964600	EUDAMED	IVD General	Active
MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control	OIM-303	EUDAMEDFDA UDI	IVD Annex II List B	Active
Alinity c Cannabinoids Control 2 Kit	09P5411	EUDAMED	IVD General	Active
MAS® Bilirubin Liquid Assayed Bilirubin Control	BC103	EUDAMEDFDA UDI	IVD General	Active
CEDIA THC OFT Negative Calibrator	10014922	EUDAMEDFDA UDI	IVD General	Active
DRI Oxycodone Calibrator 100	100250	EUDAMEDFDA UDI	IVD General	Active
QMS Zonisamide Calibrators	0373381	EUDAMEDFDA UDI	IVD General	Active
MAS ChemTrak H Liquid Assayed Chemistry Control	10014151	EUDAMEDFDA UDI	IVD General	Active
QMS Omecamtiv Mecarbil Immunoassay	10023163	EUDAMED	Class C	Active
CEDIA Methadone Assay	100097	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-UL	EUDAMEDFDA UDI	IVD General	Active
DRI THC 20 ng/mL Urine Calibrator	0235	EUDAMEDFDA UDI	IVD General	Active
MAS Diabetes Liquid Assayed Diabetes Control	DBCL-S	EUDAMEDFDA UDI	IVD General	Active
CEDIA Benzodiazepines Assay	100094	EUDAMEDFDA UDI	IVD General	Active
CEDIA Barbiturate Assay	100093	EUDAMEDFDA UDI	IVD General	Active
DRI Cotinine High Control	0470	EUDAMEDFDA UDI	IVD General	Active
Acrometrix Multi-Analyte Control HIV/HCV/HBV High	967151	EUDAMEDFDA UDI	IVD General	Active
CEDIA LSD Cutoff Calibrator	1732153	EUDAMEDFDA UDI	IVD General	Active
QMS Quinidine Calibrators	0374165	EUDAMEDFDA UDI	IVD General	Active
CEDIA® Methamphetamine OFT Controls	10014953	EUDAMEDFDA UDI	IVD General	Active
QMS Teico Rgt Kit	0374645	EUDAMED	IVD General	Active
CEDIA Procainamide Assay	100014	EUDAMEDFDA UDI	IVD General	Active
DRI Barbiturate Assay	10015648	EUDAMEDFDA UDI	IVD General	Active
DRI Ecstasy Assay	100075	EUDAMEDFDA UDI	IVD General	Active
CEDIA Bupernorphine II Controls	10020804	EUDAMEDFDA UDI	IVD General	Active
Alinity c Cocaine	09P5520	EUDAMED	IVD General	Active
DRI Cannabinoid Assay	10014665	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.