BEUDAMED
    FDA Enforcement Class II 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 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1793-2020
    Event ID
    84737
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    January 24, 2020
    Classification Date
    April 23, 2020
    Termination Date
    January 11, 2023
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    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.

    Code Info

    Instrument Serial Number AS180-00028 1035196 AS180-00067 1007580 AS180-00084 2055833 AS180-00105 2025461 AS180-00138 2025461 AS180-00179 1039938 AS180-00217 1033454 AS180-00248 1029262 AS180-00278 1031886 AS180-00300 1033400 AS180-00306 1034034 AS180-00326 1034190 AS180-00336 1041241 AS180-00339 2054793 AS180-00357 2055775 AS180-00381 1073849 AS180-00385 1054234 AS180-00398 1052053 AS180-00402 2055620 AS180-00405 1063739 AS180-00418 1042188 AS180-00420 1040343 AS180-00428 1030890 AS180-00453 1031472 AS180-00468 1043640 AS180-00476 1029272 AS180-00478 1053432 AS180-00479 1011691 AS180-00480 5001554 AS180-00481 1039588 AS180-00482 1034363 AS180-00483 1029990 AS180-00484 1049298 AS180-00485 AU01 AS180-00486 1047965 AS180-00487 1074074 AS180-00488 1000283 AS180-00489 1035594 AS180-00490 1047965 AS180-00491 1035549 AS180-00492 1070878 AS180-00493 1090075 AS180-00494 1039290 AS180-00495 1029148 AS180-00500 1007884 AS180-00509 1065153

    Distribution

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

    Quantity

    N/A