BEUDAMED
    FDA Enforcement Class II Terminated

    ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

    Recall: Z-1140-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1140-2022
    Event ID
    90126
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 1, 2022
    Initiation Date
    October 22, 2021
    Classification Date
    May 26, 2022
    Termination Date
    January 4, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

    Reason

    Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

    Code Info

    Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954

    Distribution

    US Distribution to North Carolina.

    Quantity

    6 boxes