BEUDAMED
    FDA Recall Terminated

    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.

    Recall: Z-1107-2013 · Initiated February 7, 2013

    Recall

    Recall Number
    Z-1107-2013
    Event Number
    64577
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 7, 2013
    Posted
    April 13, 2013
    Terminated
    April 20, 2017
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.

    Reason

    Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.

    Action

    URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.

    Distribution

    Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.

    Quantity

    USA: 58 units, Foreign: 103 units