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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 1 of 15

Device	Model / Reference	Registries	Class	Status
ARCHITECT Cannabinoid 100 Calibrator	3L41-03	EUDAMED	IVD General	Active
ARCHITECT Cannabinoid Reagent Kit	3L41-20	EUDAMED	IVD General	Active
ARCHITECT Opiates 300 Calibrator	3L34-02	EUDAMED	IVD General	Active
ARCHITECT DOA MC Negative Calibrator	3L43-05	EUDAMED	IVD General	Active
ARCHITECT Cannabinoid 125 Control	3L41-16	EUDAMED	IVD General	Active
ARCHITECT Cocaine Reagent Kit	3L40-20	EUDAMED	IVD General	Active
CEDIA Gentamicin II Assay (125 tests)	09086137190	EUDAMED	IVD General	Active
DRI Oxycodone Control Set 300	05178550190	EUDAMED	IVD General	Active
ARCHITECT Ethanol 300 Control	3L36-12	EUDAMED	IVD General	Active
ARCHITECT Tox Controls	6L36-10	EUDAMED	IVD General	Active
ARCHITECT Tox Calibrators 1	6L36-01	EUDAMED	IVD General	Active
ARCHITECT Tox Negative Calibator	6L36-05	EUDAMED	IVD General	Active
Alinity c Amphetamine/Methamphetamine	09P4520	EUDAMED	IVD General	Active
ARCHITECT DOA MC I Calibrator 4	3L43-04	EUDAMED	IVD General	Active
ARCHITECT Valproic Acid	1E13-20	EUDAMED	IVD General	Active
ARCHITECT Propoxyphene	6L97-20	EUDAMED	IVD General	Active
ARCHITECT Tobramycin Reagent	7F93-20	EUDAMED	IVD General	Active
ARCHITECT Ecstasy 750 Calibrator	3L42-03	EUDAMED	IVD General	Active
ARCHITECT Ethanol 50 Control	3L36-10	EUDAMED	IVD General	Active
DRI Oxycodone Control Set 100	05178568190	EUDAMED	IVD General	Active
ARCHITECT Theophylline	05P06-21	EUDAMED	IVD General	Active
ARCHITECT Tricyclic Antidepressants	6L28-20	EUDAMED	IVD General	Active
ARCHITECT DOA MC I Calibrator 2	3L43-02	EUDAMED	IVD General	Active
ARCHITECT Serum Benzodiazepines	6L30-20	EUDAMED	IVD General	Active
ARCHITECT Ethanol Reagent Kit	3L36-20	EUDAMED	IVD General	Active
ARCHITECT Digoxin Calibrator	1E06-02	EUDAMED	IVD General	Active
ARCHITECT Phenobarbital	05P07-21	EUDAMED	IVD General	Active
ARCHITECT Opiates 1000 Calibrator	3L34-04	EUDAMED	IVD General	Active
ARCHITECT TDM Multiconstituent Calibrator	5P04-01	EUDAMED	IVD General	Active
ARCHITECT Ecstasy 500 Calibrator	3L42-02	EUDAMED	IVD General	Active
ARCHITECT Cannabinoid 200 Calibrator	3L41-04	EUDAMED	IVD General	Active
ARCHITECT Ethanol Negative Calibrator	3L36-01	EUDAMED	IVD General	Active
ARCHITECT Amphetamine/Methamphetamine	3L37-20	EUDAMED	IVD General	Active
ARCHITECT DOA MC I Control	3L43-10	EUDAMED	IVD General	Active
ARCHITECT Phenytoin	05P08-21	EUDAMED	IVD General	Active
ARCHITECT Opiates 150 Calibrator	3L34-01	EUDAMED	IVD General	Active
ARCHITECT Opiates Reagent Kit	3L34-20	EUDAMED	IVD General	Active
ARCHITECT Ecstasy Reagent	3L42-20	EUDAMED	IVD General	Active
ARCHITECT Cannabinoid 60 Control	3L41-12	EUDAMED	IVD General	Active
ARCHITECT DOA MC I Calibrator 3	3L43-03	EUDAMED	IVD General	Active
ARCHITECT Tox Calibrators 3	6L36-03	EUDAMED	IVD General	Active
ARCHITECT DOA MC I Calibrator 1	3L43-01	EUDAMED	IVD General	Active
ARCHITECT Benzodiazepines	3L39-20	EUDAMED	IVD General	Active
ARCHITECT Cannabinoid 20 Calibrator	3L41-01	EUDAMED	IVD General	Active
ARCHITECT Tox Calibrators 2	6L36-02	EUDAMED	IVD General	Active
ARCHITECT Carbamazepine	05P05-21	EUDAMED	IVD General	Active
ARCHITECT Ecstasy 250 Calibrator	3L42-01	EUDAMED	IVD General	Active
ARCHITECT DOA MC 3 Controls	4P51-10	EUDAMED	IVD General	Active
DRI Oxycodone Calibrator 0	05201284190	EUDAMED	IVD General	Active
ARCHITECT Phencyclidine	6L96-20	EUDAMED	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.