BEUDAMED
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    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    FDA Recall
    Terminated ·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FCH·November 15, 2016

    American Contract Systems Biopsy Drape Pack convenience kit

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code FCH·May 6, 2024

    AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Imported and Marketed in India by Ranbaxy Fine Chemicals Ltd.; Catalogs HH7545-80.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CCH·June 12, 2006

    Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L .

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CCH·June 12, 2006

    Stereo Breast Biopsy Tray Catalog Number: 2383R1

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FCH·February 22, 2022

    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/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LNN·September 2, 2003

    PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·December 16, 2002

    Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 15, 2003

    Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·April 4, 2006

    CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JPA·March 12, 2003

    Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of the United States).

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·February 10, 2006

    Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed within the U.S.)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·November 9, 2005

    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 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

    Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CKD·July 14, 2004

    Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, 1 cartridge; catalog number 150.0051.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·May 17, 2004

    ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930.

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

    AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter model no. 777.

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

    ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 2138930.

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