BEUDAMED
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    COBAS AMPLICOR ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE INSTRUMENT CTR·Product code JJE·November 20, 2003

    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·April 19, 2017

    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·April 19, 2017

    Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JFJ·December 3, 2007

    Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code DKB·April 22, 2009

    Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code DKB·April 22, 2009

    Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·December 21, 2004

    Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·December 21, 2004

    Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112349180, Part number BP5186.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·December 21, 2004

    Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·November 12, 2008

    Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284522001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·November 12, 2008

    Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284549001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·November 12, 2008

    Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·November 12, 2008

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·February 23, 2009

    ACCU-CHEK INFORM METER

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS CORP.·Product code NBW·March 16, 2009

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code JJE·January 15, 2009

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·January 9, 2009

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS CORP.·Product code LFR·February 11, 2009

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS CORP.·Product code LFR·March 10, 2009

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·February 2, 2009