BEUDAMED
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    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LPS·April 1, 2013

    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 1, 2017

    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LPS·January 11, 2017

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 26, 2013

    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·July 9, 2014

    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LPS·June 25, 2013

    Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.

    FDA Recall
    Terminated ·Catch Incorporated·Product code LPS·January 18, 2007

    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

    FDA Enforcement
    Class III ·Terminated·CooperSurgical, Inc.·October 14, 2015

    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·January 2, 2019

    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HEE·September 1, 2015

    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code LPS·November 30, 2018

    Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034

    FDA Recall
    Terminated ·Aesculap Inc·Product code HCI·November 1, 2007

    Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034

    FDA Recall
    Terminated ·Aesculap Inc·Product code HCI·November 1, 2007

    Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

    Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

    Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

    catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405623 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405624 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405634 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405636 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405641 BD Spinal Anesthesia Tray 24G x 3.5 in. Sprotte Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405648 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog# 405649 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405682 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405684 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405685 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog#405694 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405704 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405737 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) catalog# 405829 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code CAZ·August 2, 2016

    catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405623 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405624 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405634 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405636 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405641 BD Spinal Anesthesia Tray 24G x 3.5 in. Sprotte¿ Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405648 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog# 405649 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405682 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405684 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405685 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog#405694 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405704 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405737 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) catalog# 405829 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 16, 2016

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    FDA Enforcement
    Class II ·Terminated·AcuFocus, Inc.·March 30, 2016

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    FDA Recall
    Terminated ·AcuFocus, Inc.·Product code LQE·February 11, 2016