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    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

    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

    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 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

    Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

    FDA Recall
    Open, Classified ·Alere San Diego, Inc.·Product code CGA·March 1, 2024

    Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.

    FDA Recall
    Terminated ·Alere San Diego·Product code CHH·November 16, 2010

    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

    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JJY·August 27, 2015

    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code CKD·March 6, 2013

    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code LBS·August 2, 2016

    Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.

    FDA Recall
    Terminated ·Cholestech Corp·Product code DCK·August 9, 2006

    Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code CGA·October 23, 2013

    ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

    FDA Recall
    Open, Classified ·Welch Allyn Inc Mortara·Product code DPS·September 3, 2021

    The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DCK·March 6, 2013

    Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control material for use with the Cholestech LDX System.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010

    Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used for verifying the reportable range of tests on the Cholestech LDX System.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010

    Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. Assayed quality control material for use with the Cholestech LDX System.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010

    Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712. Assayed quality control material for use with the Cholestech LDX System.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010

    Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713. Assayed quality control material for use with the Cholestech LDX System.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010

    Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, X10AXL+ DF - ARD568211710C, X10AXLDUO - ARD568211000C, X10DF - ARD568211110C, X10DF DUO - ARD568211210C, X10DF DUO - ARD568213410C, X10DF DUO - ARD568223510C, X10DF DUO - ARD568224491C, X10DF DUO - ARD568224492C, X10DF DUO - ARD568224493C, X10DF LD - ARD568213110C, X10DF LD X - ARD568223912C, X10DF LD X - ARD568223913C, X10DF V - ARD568224110C, X10DF V XD - ARD568224912C, X10DF V XS - ARD568224911C, X10DF V XS - ARD568224913C, X10LDAXL+ - ARD568213710C, X10LDAXL+ - ARD568243710C, X10SF - ARD568231110C, X10SF - ARD568244911C, X10SF DUO - ARD568231210C, X10SF DUO - ARD568233410C, X10SF DUO - ARD568243510C, X10SF DUO - ARD568244491C, X10SF DUO - ARD568244492C, X10SF DUO - ARD568244493C, X10SF LD - ARD568233110C, X10SF LD X - ARD568243911C, X10SF TRIO - ARD568244440C, X10SF V - ARD568244110C, X10VAXL+ D - ARD568224710C, X10VAXL+ D - ARD568224791C, X10VAXL+ D - ARD568224792C, X10VAXL+ SF - ARD568244710C, X10VAXL+ SF - ARD568244791C, X10VAXL+ SF - ARD568244792C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023