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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 7 of 15

Device	Model / Reference	Registries	Class	Status
DRI Ecstasy Plus Assay	K240670	FDA 510(k)	Class II	Active
Cedia(tm) T Uptake	K872447	FDA 510(k)	Class II	Active
Cedia(tm) Phenobarbital Assay	K904413	FDA 510(k)	Class II	Active
Cedia Dau Barbiturate Assay	K942436	FDA 510(k)	Class II	Active
Cedia (r) Vitamin B12/Folate Assay	K904776	FDA 510(k)	Class II	Active
Cedia(r) Carbamazepine Assay	K914857	FDA 510(k)	Class II	Active
Cedia Dau Amphetamines Assay	K943993	FDA 510(k)	Class II	Active
Cedia Dau Cocaine Assay Hitachi 717 And 704 Analyzers	K935904	FDA 510(k)	Class II	Active
Cedia Valporic Acid Assay	K930734	FDA 510(k)	Class II	Active
Cedia Dau Amphetamines Assay	K941372	FDA 510(k)	Class II	Active
Modified Cedia(tm) Cortisol Assay	K896451	FDA 510(k)	Class II	Active
Microgenics Thc Control Sets	K943048	FDA 510(k)	Class I	Active
QMS Plazomicin Immunoassay	DEN180030	FDA 510(k)	Class II	Active
Cedia T4 Mab Assay	K942575	FDA 510(k)	Class II	Active
Thermo Scientific Dri Amphetamines Assay	K093114	FDA 510(k)	Class II	Active
MAS Liquimmune Liquid Assayed Immunoassay Control	LIG-202	EUDAMEDFDA UDI	IVD Annex II List B	Active
CEDIA Bupernorphine II 0ng/mL Calibrator	10021390	EUDAMEDFDA UDI	IVD General	Active
QMS Gentamycin Immunoassay	10014390	EUDAMEDFDA UDI	IVD General	Active
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control	OCRD-303	EUDAMEDFDA UDI	IVD General	Active
CEDIA Theophylline II Assay	100008	EUDAMEDFDA UDI	IVD General	Active
DRI Barbiturate Assay	0225	EUDAMEDFDA UDI	IVD General	Active
CEDIA DAU THC 100 Control Set	1661060	EUDAMEDFDA UDI	IVD General	Active
Hema-Trol	HYC84667	EUDAMEDFDA UDI	IVD General	Active
DRI Methadone Metabolite Assay	10018522	EUDAMEDFDA UDI	IVD General	Active
CEDIA PPX/METD High Calibrator	1662864	EUDAMEDFDA UDI	IVD General	Active
CEDIA Mycophenolic Acid Calibrators	100277	EUDAMEDFDA UDI	IVD General	Active
Alinity c Opiates Qual Calibrator Kit	09P6501	EUDAMED	IVD General	Active
Alinity c Serum Benzodiazepines	09P5320	EUDAMED	IVD General	Active
CEDIA DAU THC 25 Control Set	1661086	EUDAMEDFDA UDI	IVD General	Active
Alinity c Tobramycin Calibrators	09P9001	EUDAMED	IVD General	Active
MAS Urinalysis Liquid Urinalysis Control 3	024224	EUDAMEDFDA UDI	IVD General	Active
CEDIA Buprenorphine 75 ng/mL Calibrator	100245	EUDAMEDFDA UDI	IVD General	Active
DRI Amphetamine Assay	0018	EUDAMEDFDA UDI	IVD General	Active
DRI Serum Tox Calibrator 2	0965	EUDAMEDFDA UDI	IVD General	Active
AcroMetrix HBVDNA+	961241	EUDAMED	IVD General	Active
DRI Ecstasy Assay	100076	EUDAMEDFDA UDI	IVD General	Active
Acrometrix WNVRNA (10 x 1.4 mL)	960500	EUDAMEDFDA UDI	IVD General	Active
CEDIA Benzodiazepine Assay	10016409	EUDAMEDFDA UDI	IVD General	Active
MAS DOA Total® Liquid Assayed Drugs of Abuse Control	DOAT-3	EUDAMEDFDA UDI	IVD General	Active
MAS ChemTrak H Liquid Assayed Chemistry Control	10014152	EUDAMEDFDA UDI	IVD General	Active
Acrometrix EV Low Control	960501	EUDAMEDFDA UDI	IVD General	Active
CEDIA Bupernorphine II 50ng/mL Calibrator	10020801	EUDAMEDFDA UDI	IVD General	Active
MAS UA Control Liquid Assayed Urinalysis Control	UAB-215	EUDAMEDFDA UDI	IVD General	Active
Alinity c DOA MC I Controls	08P6310	EUDAMED	IVD General	Active
DRI THC 125 ng/mL Urine Control	0212	EUDAMEDFDA UDI	IVD General	Active
CEDIA MultiDrug Optional Controls	100069	EUDAMEDFDA UDI	IVD General	Active
DRI THC 200 ng/mL Urine Calibrator	0206	EUDAMEDFDA UDI	IVD General	Active
MAS Immunology Liquid Assayed Immunology Control	IC-V2	EUDAMEDFDA UDI	IVD General	Active
MAS Diabetes Liquid Assayed Diabetes Control	DBCL-MP	EUDAMEDFDA UDI	IVD General	Active
MAS® Bilirubin Liquid Assayed Bilirubin Control	BC101	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.