BEUDAMED
    FDA Recall Terminated

    Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

    Recall: Z-0116-2019 · Initiated July 24, 2018

    Recall

    Recall Number
    Z-0116-2019
    Event Number
    80954
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JHS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 24, 2018
    Terminated
    May 26, 2020
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

    Reason

    A potential bias was identified with certain kits compared to the internal standards.

    Action

    On July 24, 2018 Siemens Healthineers issued Urgent Medical Device Recall notices to U.S. customers and Urgent Field Safety Notices to OUS customers. The following are Actions to be Taken by the Customer: Customers using ADVIA Centaur CKMB Calibrator Lots ending in 64: - Review the notice with your Medical Director. - Review your inventory of these products and immediately order replacement ADVIA Centaur CKMB Calibrator kit lots ending in 68 by completing the Field Correction Effectiveness Check Form attached to the letter. - You may continue use of ADVIA Centaur CKMB Calibrator kit lots until replacement product is received in your laboratory. - Upon receipt of replacement product in your laboratory, discontinue use of and discard the ADVIA Centaur CKMB Calibrator kit lots listed in Table 1 of the letter. - ADVIA Centaur CKMB Calibrator kit lots ending in 63 may continue to be used until the assigned expiration date. - Refer to the Additional Information section for expected patient sample bias when transitioning to ADVIA Centaur CKMB Calibrator kit lots ending in 68. Customers using ADVIA Centaur Master Curve Material: - Discontinue use of and discard the ADVIA Centaur MCM lots in Table 1. - Review your inventory of these products and order replacement ADVIA Centaur CKMB Master Curve Material by completing the Field Correction Effectiveness Check Form attached to the letter. - Utilize ADVIA Centaur CKMB MCM Lot 13384 and future lots. - Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Customers using Atellica IM CKMB Calibrator Lots ending in 66: - Review your inventory of these products and immediately order replacement Atellica IM CKMB Calibrator kit lots ending in 69 by completing the Field Correction Effectiveness Check Form attached to the letter. - You may continue use of Atellica IM CKMB Calibrator kit lots in Table 1 until replacement product is received in your laboratory

    Distribution

    US Nationwide Distribution

    Quantity

    97 kits