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    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJL·October 25, 2012

    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

    Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LBS·March 17, 2016

    Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·November 10, 2009

    HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LBS·April 3, 2017

    Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code JIS·December 22, 2020

    PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CGA·August 4, 2009

    Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (lowdensity lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code CGA·February 18, 2011

    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LBS·May 7, 2015

    The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987

    FDA Recall
    Open, Classified ·Alere San Diego, Inc.·Product code CGA·June 24, 2022

    Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JJY·October 22, 2012

    PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code NBW·July 6, 2010

    BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code CAZ·April 27, 2026

    BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code CAZ·April 27, 2026

    BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code CAZ·April 27, 2026

    BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code CAZ·April 27, 2026

    BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code CAZ·April 27, 2026