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Microgenics Corporation

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
21
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0415-2026Class IIThermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: October 1, 2025
Z-1284-2022Class IIQMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROJanuary 20, 2022
Z-0008-2017Class IIThermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (ForeignAugust 15, 2016
Z-2884-2016Class IIDRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox AsJuly 25, 2016
Z-0501-2015Class IIMAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical labOctober 20, 2014
Z-1930-2014Class IIIMAS Omni Immune PRO ControlsDecember 2, 2013
Z-1929-2014Class IIIMAS Omni Immune ControlsDecember 2, 2013
Z-1563-2013Class IIThermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured aMay 13, 2013
Z-0379-2013Class IIIThermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay ControAugust 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K243498Alinity c Benzodiazepines Reagent KitDecember 11, 2024
K240670DRI Ecstasy Plus AssayOctober 30, 2024
K231020Alinity c Tricyclic Antidepressants Reagent KitNovember 17, 2023
K231007CEDIA Heroin Metabolite (6-AM) AssaySeptember 27, 2023
K213875DRI TM Tricyclics Serum Tox AssayDecember 21, 2022
K211973DRI Cocaine Metabolite AssaySeptember 24, 2021
K192943CEDIA Heroin Metabolite (6-AM) assayDecember 16, 2019
K190968CEDIA Benzodiazepine AssayDecember 9, 2019
DEN180030QMS Plazomicin ImmunoassayNovember 19, 2018
K181499DRI Cocaine Metabolite AssayJuly 6, 2018
K173963DRI Benzodiazepine AssayFebruary 21, 2018
K173195DRI Hydrocodone AssayFebruary 13, 2018
K173183CEDIA Heroin Metabolite (6-AM) AssayNovember 22, 2017
K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIApril 6, 2017
K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsOctober 9, 2015
K123518ABBOTT CARBAMAZEPINE ASSAYJune 5, 2013
K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSDecember 13, 2012
K122291THERMO SCIENTIFIC MAS OMNI-CARDIOAugust 31, 2012
K110738THERMO SCIENTIFIC MAS OMNI-CORENovember 3, 2011
K103656THERMO SCIENTIFIC MAS R DOA TOTALMarch 24, 2011