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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 6 of 15

Device	Model / Reference	Registries	Class	Status
Cedia Dau Cocaine Assay	K945345	FDA 510(k)	Class II	Active
Thermo Scientific Qms Tacrolimus Assay And Calibrators	K123343	FDA 510(k)	Class II	Active
Thermo Scientific Mas R Doa Total	K103656	FDA 510(k)	Class I	Active
Thermo Scientific Cedia Amphetamine Oft Assay	K101745	FDA 510(k)	Class II	Active
Cedia Dau Benzodiazepine Assay	K951710	FDA 510(k)	Class II	Active
Thermo Scientific Cedia Phencyclidine (pcp) Oft Assay	K101746	FDA 510(k)	U	Active
Cedia Dau Negative Calibrator	K935793	FDA 510(k)	Class II	Active
Cedia (tm) Cortisol Assay	K901296	FDA 510(k)	Class II	Active
Cedia T4 Mab Assay	K941042	FDA 510(k)	Class II	Active
Modified Cedia Total T4 Assay	K884634	FDA 510(k)	Class II	Active
Modification Of The Cedia Digoxin Assay	K884054	FDA 510(k)	Class II	Active
Cedia Vancomycin Assay	K032811	FDA 510(k)	Class II	Active
Abbott Carbamazepine Assay	K123518	FDA 510(k)	Class II	Active
Cedia Dau Barbiturate Assay	K936030	FDA 510(k)	Class II	Active
Thermo Scientific Qms Everolimus Assay	K122766	FDA 510(k)	Class II	Active
Cedia Digoxin Plus Assay	K923853	FDA 510(k)	Class II	Active
Cedia(r) Folate (no Boil) Assay	K946184	FDA 510(k)	Class II	Active
Cedia Dau Methadone Assay	K954227	FDA 510(k)	Class II	Active
Cedia T4 Mab Assay	K943019	FDA 510(k)	Class II	Active
Cedia(r) Dau Bar/Benz 300, 300 Intermed & High Calib	K936028	FDA 510(k)	Class II	Active
Cedia Dau 4-Drug Cutoff Calibrator	K935794	FDA 510(k)	Class II	Active
Cedia Dau Multi-Level Thc Assay	K935591	FDA 510(k)	Class II	Active
Cedia Sirolimus Assay	DEN040008	FDA 510(k)	Class II	Active
Dri Ecstasy Urine Calibrators	K012109	FDA 510(k)	Class II	Active
Thermo Scientific Cyto-Cal Count Tubes	K090810	FDA 510(k)	Class II	Active
Document Salicylate Cal Ver	K041073	FDA 510(k)	Class I	Active
Cedia Dau Amphetamines/Ecstasy Assay	K010496	FDA 510(k)	Class II	Active
Cedia Dau Opiate Assay	K945343	FDA 510(k)	Class II	Active
Thermo Scientific Cedia Cocaine Oft Assay	K101742	FDA 510(k)	Class II	Active
Cedia Red Blood Cell Folate Reagent Pack	K921689	FDA 510(k)	Class II	Active
Cedia Phenytoin Assay	K905689	FDA 510(k)	Class II	Active
Cedia Dau Amphassure Assay	K994380	FDA 510(k)	Class II	Active
Thermo Scientific Cedia Methamphetamine Oft Assay	K101753	FDA 510(k)	Class II	Active
Cedia(r) Dau Barbiturate Assay, Modification	K942404	FDA 510(k)	Class II	Active
Cedia Digoxin Assay	K854638	FDA 510(k)	Class II	Active
Cedia Dau 5-Drug Calibrators	K935792	FDA 510(k)	Class II	Active
Thermo Scientific Mas Omni-Immune, Mas Omni Immune Pro	K110616	FDA 510(k)	Class I	Active
Cedia Dau Cocaine Assay	K941310	FDA 510(k)	Class II	Active
Cedia Dau Multi-Level Thc Assay, Hitachi 911 Reagent/ And The Hitachi 747 Reagent	K940649	FDA 510(k)	Class II	Active
Cedia Dau Benzodiazepine Assay(modification)	K954626	FDA 510(k)	Class II	Active
Cedia Folate (no Boil) Assay	K951155	FDA 510(k)	Class II	Active
Dri Ecstasy Enzyme Immunoassay	K012110	FDA 510(k)	Class II	Active
Thermo Scientific Qms Everolimus Reagents, Calibrators And Controls	K100144	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls	K150502	FDA 510(k)	Class II	Active
Cedia Total T3 Assay	K904098	FDA 510(k)	Class II	Active
Dri Hemoglobin A1c Assay And Calibrators	K053411	FDA 510(k)	Class II	Active
Cedia Vitamin B12 (no Boil) Assay	K951134	FDA 510(k)	Class II	Active
Alinity c Tricyclic Antidepressants Reagent Kit	K231020	FDA 510(k)	Class II	Active
Cedia Dau Benzodiazepine Assay	K942795	FDA 510(k)	Class II	Active
Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158	K092051	FDA 510(k)	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.