BEUDAMED
    FDA Enforcement Class III Terminated

    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.

    Recall: Z-0389-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0389-2019
    Event ID
    81160
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtest Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 14, 2018
    Initiation Date
    August 10, 2018
    Classification Date
    November 5, 2018
    Termination Date
    December 4, 2019
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    Description

    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.

    Reason

    Vials of the autoHDL/LDL Calibrator were shipped without a vial label.

    Code Info

    Lot Number 808801-180; UDI: 00811727011411

    Distribution

    US Nationwide in the states of CA, FL, GA, MI, and OH.

    Quantity

    22