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Microgenics Corporation

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalo recall (Z-0415-2026)Microgenics Corporation2025-10-30
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 ( recall (Z-0008-2017)Microgenics Corporation2016-10-03
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum recall (Z-2884-2016)Microgenics Corporation2016-09-23
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinic recall (Z-0501-2015)Microgenics Corporation2014-12-04
MAS Omni Immune Controls recall (Z-1929-2014)Microgenics Corporation2014-06-26
MAS Omni Immune PRO Controls recall (Z-1930-2014)Microgenics Corporation2014-06-26
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manu recall (Z-1563-2013)Microgenics Corporation2013-06-21
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoass recall (Z-0379-2013)Microgenics Corporation2012-11-19
ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Ma recall (Z-0637-2012)Microgenics Corporation2012-01-11

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Every clearance here is in the API, with alerts when new ones post.