BEUDAMED
    FDA Recall Terminated

    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

    Recall: Z-0574-2020 · Initiated November 7, 2019

    Recall

    Recall Number
    Z-0574-2020
    Event Number
    84238
    Firm
    Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
    FEI Number
    3002809144
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 7, 2019
    Posted
    November 26, 2019
    Terminated
    August 31, 2023

    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.

    Action

    The firm initiated the recall by letter on 11/07/2019. The letter explained the issue and requested that the consignee discontinue use of the product and destroy it. The firm is providing replacement material.

    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