Microgenics Corp.

• KXT — Clinical Toxicology9 devices
• DJG — Clinical Toxicology7 devices
• DKZ — Clinical Toxicology7 devices
• KLI — Clinical Chemistry6 devices
• DKB — Clinical Toxicology5 devices
• DLJ — Clinical Toxicology5 devices
• LAS — Clinical Toxicology5 devices
• LDJ — Clinical Toxicology5 devices
• DIO — Clinical Toxicology4 devices
• DIS — Clinical Toxicology4 devices

• Z-0513-2014 — Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.Class II·Terminated·2013-10-16
• Z-2267-2013 — DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.Class II·Terminated·2013-07-23

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.

• K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYCode OUF·2013-08-20
• K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSCode MLM·2013-07-11
• K123271 — ABBOTT PHENOBARBITAL ASSAYCode DLZ·2013-04-26
• K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROCode JJY·2011-06-29
• K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYCode DIO·2011-04-08
• K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAYCode LDJ·2011-04-08
• K101745 — THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAYCode DKZ·2011-04-08
• K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYCode LCM·2011-04-08
• K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSCode DKB·2011-04-08
• K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAYCode LAF·2011-04-08
• K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYCode DJG·2011-04-08
• K100144 — THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLSCode OUF·2011-02-11
• K093114 — THERMO SCIENTIFIC DRI AMPHETAMINES ASSAYCode DKZ·2010-05-12
• K092051 — THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158Code JJY·2009-09-21
• K090810 — THERMO SCIENTIFIC CYTO-CAL COUNT TUBESCode GKZ·2009-09-18
• K061196 — CARDIOIMMUNE XL CARDIAC MARKER CONTROLCode JJY·2006-05-30
• K053411 — DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORSCode LCP·2006-02-03
• K051074 — MAS IMMUNOSUPPRESSANT CONTROLSCode LAS·2005-06-06
• K050206 — CEDIA TACROLIMUS ASSAYCode MLM·2005-03-15
• DEN040008 — CEDIA SIROLIMUS ASSAYCode NRP·2004-07-28
• K040316 — CEDIA BUPRENORPHINE ASSAYCode DJG·2004-06-23
• K040758 — MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECTCode DIF·2004-05-28
• K040411 — DRI OXYCODONE ASSAYCode LAS·2004-05-27
• K041073 — DOCUMENT SALICYLATE CAL VERCode JJY·2004-05-21
• K032811 — CEDIA VANCOMYCIN ASSAYCode LEH·2003-11-24
• K032842 — MICROGENICS CYCLOSPORINE CONTROL KITCode LAS·2003-10-17
• K023617 — DRI METHADONE METABOLITE ENZYME IMMUNOASSAYCode DJR·2003-08-27
• K030649 — DRI COTININE EIA ASSAYCode MRS·2003-05-22
• K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5Code LAS·2003-03-31
• K023780 — DRI PRIMIDONE CALIBRATORSCode DLJ·2003-02-10
• K023208 — CEDIA CYCLOSPORINE PLUS ASSAYCode MKW·2002-10-24
• K012109 — DRI ECSTASY URINE CALIBRATORSCode DLJ·2001-08-27
• K012110 — DRI ECSTASY ENZYME IMMUNOASSAYCode DKZ·2001-08-27
• K011150 — DRIDAU OPIATE ASSAYCode DJG·2001-06-20
• K010496 — CEDIA DAU AMPHETAMINES/ECSTASY ASSAYCode LAF·2001-05-29
• K001178 — CEDIA DAU 6-ACETYLMORPHINE ASSAYCode DJG·2000-06-09
• K994380 — CEDIA DAU AMPHASSURE ASSAYCode DKZ·2000-05-02
• K955813 — CEDIA DAU LSD CALBIRATORSCode DLJ·1996-02-09
• K955814 — CEDIA DAU LSD ASSAYCode DLB·1996-02-09
• K954626 — CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)Code JXM·1995-11-27
• K954227 — CEDIA DAU METHADONE ASSAYCode DJR·1995-11-17
• K951134 — CEDIA VITAMIN B12 (NO BOIL) ASSAYCode CDD·1995-07-11
• K951155 — CEDIA FOLATE (NO BOIL) ASSAYCode CGN·1995-06-29
• K951710 — CEDIA DAU BENZODIAZEPINE ASSAYCode JXM·1995-06-20
• K951154 — CEDIA DAU AMPHETAMINES ASSAYCode DKZ·1995-05-08
• K951133 — CEDIA DAU PROPOXYPHENE ASSAYCode JXN·1995-05-02
• K951153 — CEDIA DAU PPX/METH CALIBRATORCode DLJ·1995-04-21
• K951135 — MULTI-DRUG CONTROL SETCode DIF·1995-04-13
• K945343 — CEDIA DAU OPIATE ASSAYCode DJG·1995-01-17
• K945345 — CEDIA DAU COCAINE ASSAYCode DIO·1995-01-17
• K946059 — CEDIA(R) DAU PCP ASSAYCode LCM·1995-01-17
• K946184 — CEDIA(R) FOLATE (NO BOIL) ASSAYCode CGN·1995-01-17
• K945344 — CEDIA DAU BARBITURATE ASSAYCode DIS·1994-12-28
• K944562 — MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATIONCode LDJ·1994-11-02
• K943993 — CEDIA DAU AMPHETAMINES ASSAYCode DKZ·1994-10-21
• K943019 — CEDIA T4 MAB ASSAYCode KLI·1994-10-20
• K941195 — CEDIA DAU OPIATE ASSAYCode DJG·1994-09-07
• K942436 — CEDIA DAU BARBITURATE ASSAYCode DIS·1994-08-30
• K943048 — MICROGENICS THC CONTROL SETSCode LAS·1994-08-24
• K942337 — CEDIA DAU MULTI-LEVEL THC ASSAYCode LDJ·1994-08-01
• K942795 — CEDIA DAU BENZODIAZEPINE ASSAYCode JXM·1994-08-01
• K942404 — CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATIONCode DIS·1994-07-28
• K942575 — CEDIA T4 MAB ASSAYCode KLI·1994-07-28
• K941372 — CEDIA DAU AMPHETAMINES ASSAYCode DKZ·1994-07-20
• K941255 — CEDIA DIGOXIN PLUS ASSAYCode KXT·1994-06-13
• K941310 — CEDIA DAU COCAINE ASSAYCode DIO·1994-06-02
• K940159 — CEDIA DAU BENZODIAZEPINE ASSAYCode JXM·1994-05-27
• K940649 — CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENTCode LDJ·1994-05-17
• K941042 — CEDIA T4 MAB ASSAYCode KLI·1994-04-26
• K935795 — CEDIA DAU THC CALIBRATORSCode DLJ·1994-04-06
• K935650 — CEDIA(R) DAU PCP ASSAYCode LCM·1994-04-05
• K936030 — CEDIA DAU BARBITURATE ASSAYCode DIS·1994-03-22
• K935793 — CEDIA DAU NEGATIVE CALIBRATORCode DKB·1994-03-14
• K936028 — CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIBCode DKB·1994-03-14
• K935904 — CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERSCode DIO·1994-03-11
• K935880 — CEDIA T4 MAB ASSAY MODIFICATIONCode KLI·1994-03-03
• K935792 — CEDIA DAU 5-DRUG CALIBRATORSCode DKB·1994-01-25
• K935794 — CEDIA DAU 4-DRUG CUTOFF CALIBRATORCode DKB·1994-01-25
• K935591 — CEDIA DAU MULTI-LEVEL THC ASSAYCode LDJ·1994-01-13
• K935346 — CEDIA(R) DAU OPIATE ASSAYCode DJG·1994-01-11
• K934168 — CEDIA DIGOXIN PLUS ASSAYCode KXT·1993-12-29
• K930734 — CEDIA VALPORIC ACID ASSAYCode LEG·1993-09-21
• K923853 — CEDIA DIGOXIN PLUS ASSAYCode KXT·1992-09-15
• K921689 — CEDIA RED BLOOD CELL FOLATE REAGENT PACKCode CGN·1992-06-16
• K920318 — CEDIA FERRITIN ASSAYCode JMG·1992-06-04
• K920214 — CEDIA DIGOXIN ASSAY (MODIFICATION)Code KXT·1992-03-02
• K914857 — CEDIA(R) CARBAMAZEPINE ASSAYCode KLT·1992-01-15
• K913470 — CEDIA(R) GENTAMICIN ASSAYCode LCD·1991-09-27
• K912143 — CEDIA(R) TOBRAMYCIN ASSAYCode LFW·1991-07-26
• K911941 — CEDIA(R) DIGOXIN R' ASSAYCode KXT·1991-05-15
• K910642 — CEDIA(R) DIGOXIN SC ASSAYCode KXT·1991-03-21
• K905689 — CEDIA PHENYTOIN ASSAYCode DIP·1991-01-17
• K905521 — CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATIONCode LER·1990-12-26
• K904776 — CEDIA (R) VITAMIN B12/FOLATE ASSAYCode CDD·1990-11-20
• K904413 — CEDIA(TM) PHENOBARBITAL ASSAYCode LAF·1990-11-05
• K904098 — CEDIA TOTAL T3 ASSAYCode CDP·1990-09-27
• K901296 — CEDIA (TM) CORTISOL ASSAYCode CGR·1990-04-03
• K896451 — MODIFIED CEDIA(TM) CORTISOL ASSAYCode CGR·1989-12-12
• K896021 — CEDIA DIGITOXIN ASSAYCode LFM·1989-11-08
• K893954 — CEDIA CORTISOL ASSAYCode JFT·1989-10-31