BEUDAMED
    FDA Enforcement Class II Terminated

    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

    Recall: Z-0574-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0574-2020
    Event ID
    84238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Gmbh & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    November 7, 2019
    Classification Date
    November 25, 2019
    Termination Date
    August 31, 2023
    Address
    Max-Planck-Ring 2, 65205, Wiesbaden, N/A, Germany

    Description

    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

    Reason

    Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.

    Code Info

    lot number 08219BE00

    Distribution

    US in the states of: AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV

    Quantity

    83 kits