BEUDAMED
    FDA Recall Terminated

    Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

    Recall: Z-1796-2018 · Initiated December 14, 2017

    Recall

    Recall Number
    Z-1796-2018
    Event Number
    79468
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 14, 2017
    Terminated
    December 3, 2020
    Address
    500 Gbc Dr Po Box 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

    Reason

    Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.

    Action

    Customers are instructed to: - Discontinue use of Dimension LIPL Assay lot FB8109. - Recalibrate with an alternate lot of Dimension LIPL Assay. - Review their inventory of this lot to determine their laboratoryfs no-charge replacement needs. - Review the UMDR/UFSN letter with their Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days. - If they have received any complaints of illness or adverse events associated with lot FB8109, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative

    Distribution

    Domestic and Foreign consignees