BEUDAMED
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    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

    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

    PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·February 20, 2009

    Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX Analyzer.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JJE·February 15, 2019

    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.

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

    Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (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 plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.

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

    Dimension Assays: Direct HDL Cholesterol (AHDL)

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

    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

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

    CHOL+HDL+GLU test strips, REF 2412

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CGA·January 16, 2019