BEUDAMED
    133 results · 30ms · Sources: EU EUDAMED, US FDA

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

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JQP·March 1, 2017

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

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JQP·March 1, 2017

    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

    cobas c513 Analyzer

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·July 18, 2019

    Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LEH·July 23, 2019

    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LEH·July 23, 2019

    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·July 18, 2019

    Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CIG·September 11, 2019

    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·July 18, 2019

    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CIX·September 11, 2019

    Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.

    FDA Recall
    Terminated ·Seradyn, Inc.·Product code LEH·December 20, 2007

    COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code PDJ·October 4, 2016

    Elecsys PreciControl Varia 3

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JJY·April 10, 2017

    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LCD·October 7, 2009

    Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LCD·October 7, 2009

    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LCD·October 7, 2009

    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

    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    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