BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1140-2022 · Initiated October 22, 2021

    Recall

    Recall Number
    Z-1140-2022
    Event Number
    90126
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    CIC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 22, 2021
    Terminated
    January 4, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.

    Distribution

    US Distribution to North Carolina.

    Quantity

    6 boxes