BEUDAMED
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    ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with meter model no. 3288650.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version for the blind or visually impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no. 768.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·June 22, 2006

    Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or 100s) 03144917001, 03144704001, 03145263001 and International Reference nos. 12030551001, 12030578001 and 12030586001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·June 27, 2006

    Accu-Chek Advantage II blood glucose test strips; International Reference nos. 12030659001, 12030667001, 03137872001, 03137899001, 03000281001, 12030535001, 12030543001, 03033449001, 03033465001 and 12030543047.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·June 27, 2006

    Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code KLB·April 5, 2007

    Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGX·June 11, 2008

    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 ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NBW·June 10, 2009

    Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 21, 2003

    Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JQW·May 5, 2004

    Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 15, 2005

    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

    Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JJE·March 21, 2017

    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JJE·April 3, 2018

    Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code KHP·December 17, 2018

    COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·May 5, 2004

    CoaguChek PT test strips, sold in 12 pack.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JPA·February 20, 2003

    Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LCP·February 15, 2005

    Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·June 24, 2008

    Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 21, 2003