BEUDAMED
    FDA Recall Terminated

    PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).

    Recall: Z-1793-2020 · Initiated January 24, 2020

    Recall

    Recall Number
    Z-1793-2020
    Event Number
    84737
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 24, 2020
    Terminated
    January 11, 2023
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).

    Reason

    The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.

    Action

    The firm initiated the recall by letter on 01/15/2020. The Urgent Product Correction Notice instructed the customer the to provide the letter to all appropriate personnel within their organization. The letter instructs the personnel to check their inventory against the serial numbers listed in Appendix A of the letter. The letter also details that a bioMerieux Field Service Engineer will be contacting the customer to schedule a service appointment and if necessary, replace the PSU.

    Distribution

    Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.