BEUDAMED
    FDA Recall Terminated

    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    Recall: Z-1936-2019 · Initiated April 8, 2019

    Recall

    Recall Number
    Z-1936-2019
    Event Number
    82784
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 8, 2019
    Terminated
    November 12, 2020
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    Reason

    Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

    Action

    On 08 April 2019, a customer letter (Ref. CL2019-090) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) to either all customers who were shipped affected VITROS 250 or 350 Systems. This communication provided the following required actions: - As per the VITROS CK Slide Instructions for Use, perform Quality Control (QC) testing daily to help ensure the slides are performing within acceptable limits. - If QC results are outside of the established ranges, discard the cartridge and repeat QC testing using a fresh cartridge of VITROS CK Slides. - If multiple cartridges are loaded on the VITROS 250/350 System, daily QC testing must be performed for each cartridge prior to use. - Consider loading one cartridge of VITROS CK Slides on board your system at a time. - Complete and return the request form via fax to 1-888-557-3759. Foreign affiliates were informed by email on 08 April 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take.

    Distribution

    US Nationwide Distribution

    Quantity

    3889 units