Microgenics Corporation

• DJG — Clinical Toxicology6 devices
• JXM — Clinical Toxicology3 devices
• DIO — Clinical Toxicology2 devices
• JJY — Clinical Chemistry2 devices
• LFH — Clinical Toxicology2 devices
• DIF — Clinical Toxicology1 device
• DKB — Clinical Toxicology1 device
• DKZ — Clinical Toxicology1 device
• JJX — Clinical Chemistry1 device
• KLT — Clinical Toxicology1 device

• Z-0415-2026 — Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external controlClass II·Ongoing·2025-10-01
• Z-1284-2022 — QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3Class II·Ongoing·2022-01-20
• Z-0008-2017 — Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.Class II·Terminated·2016-08-15
• Z-2884-2016 — DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.Class II·Terminated·2016-07-25
• Z-0501-2015 — MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.Class II·Terminated·2014-10-20
• Z-1929-2014 — MAS Omni Immune ControlsClass III·Terminated·2013-12-02
• Z-1930-2014 — MAS Omni Immune PRO ControlsClass III·Terminated·2013-12-02
• Z-1563-2013 — Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.Class II·Terminated·2013-05-13
• Z-0379-2013 — Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .Class III·Terminated·2012-08-20

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K243498 — Alinity c Benzodiazepines Reagent KitCode JXM·2024-12-11
• K240670 — DRI Ecstasy Plus AssayCode DKZ·2024-10-30
• K231020 — Alinity c Tricyclic Antidepressants Reagent KitCode LFH·2023-11-17
• K231007 — CEDIA Heroin Metabolite (6-AM) AssayCode DJG·2023-09-27
• K213875 — DRI TM Tricyclics Serum Tox AssayCode LFH·2022-12-21
• K211973 — DRI Cocaine Metabolite AssayCode DIO·2021-09-24
• K192943 — CEDIA Heroin Metabolite (6-AM) assayCode DJG·2019-12-16
• K190968 — CEDIA Benzodiazepine AssayCode JXM·2019-12-09
• DEN180030 — QMS Plazomicin ImmunoassayCode QDR·2018-11-19
• K181499 — DRI Cocaine Metabolite AssayCode DIO·2018-07-06
• K173963 — DRI Benzodiazepine AssayCode JXM·2018-02-21
• K173195 — DRI Hydrocodone AssayCode DJG·2018-02-13
• K173183 — CEDIA Heroin Metabolite (6-AM) AssayCode DJG·2017-11-22
• K163101 — CEDIA Buprenorphine II Assay +3 moreCode DJG·2017-04-06
• K150502 — DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsCode DJG·2015-10-09
• K123518 — ABBOTT CARBAMAZEPINE ASSAYCode KLT·2013-06-05
• K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSCode DKB·2012-12-13
• K122291 — THERMO SCIENTIFIC MAS OMNI-CARDIOCode JJY·2012-08-31
• K110738 — THERMO SCIENTIFIC MAS OMNI-CORECode JJY·2011-11-03
• K103656 — THERMO SCIENTIFIC MAS R DOA TOTALCode DIF·2011-03-24
• K092749 — MAS AND MINI-TROL PTH CONTROLCode JJX·2009-12-03