BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

    Recall: Z-2481-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2481-2020
    Event ID
    85762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 8, 2020
    Initiation Date
    May 20, 2020
    Classification Date
    July 1, 2020
    Termination Date
    November 16, 2022
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

    Reason

    Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

    Code Info

    Affected Serial Number : 36000192 36000396 36000430 36000431 36000446 36000468 36000504 36000517 36000577 36000580 36000585 36000631 36000647 36000366 36000267 36000386 36000404 36000420 36000562 36000614 36000575 36000589 36000480 36000582 36000687 36000492 36001042

    Distribution

    US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN

    Quantity

    27 ( U.S.= 0; OUS= 27)