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    Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·November 10, 2011

    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KLI·August 26, 2010

    Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·November 10, 2011

    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

    EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

    EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

    EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

    EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46

    FDA Recall
    Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

    VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820

    FDA Recall
    Open, Classified ·QUIDELORTHO·Product code JIS·April 9, 2024

    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIS·April 15, 2025

    AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code JIS·March 6, 2008

    Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIS·September 7, 2006

    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code JIS·November 29, 2018

    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JIS·July 27, 2011

    ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JIS·March 13, 2013

    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code JIS·March 8, 2022

    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIS·April 15, 2025

    ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JIS·March 13, 2013

    Synchron Systems Lipid Calibrator (HDLD) Part 650218

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JIS·October 3, 2003