120 results
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38ms
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Sources: EU EUDAMED, US FDA
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Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JIX·September 15, 2008
Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code MKW·August 13, 2010
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LAN·February 5, 2010
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJY·December 4, 2007
Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis 46250.(**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJF·August 30, 2007
Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CIC·October 11, 2010
Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20751995190. Roche Diagnostics Corporation, Indianapolis, IN 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JIX·November 14, 2007
Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog. No. 20752401190. Roche Diagnostics Corporation, Indianapolis, IN 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJY·November 14, 2007
Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roche Diagnostics Corporation, Indianapolis, IN
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJY·November 14, 2007
Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LDP·December 7, 2010
Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03284549001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·March 21, 2008
Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·March 21, 2008
Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog number 03284522001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·March 21, 2008
Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·March 21, 2008
Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LDP·December 7, 2010
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·March 21, 2008
Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CIC·October 11, 2010
Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code MMI·March 12, 2012
Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code MMI·March 12, 2012
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG CT Detection Kit
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code MKZ·July 7, 2004