BEUDAMED
    FDA Recall Terminated

    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.

    Recall: Z-1521-2015 · Initiated March 10, 2015

    Recall

    Recall Number
    Z-1521-2015
    Event Number
    70685
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    March 10, 2015
    Posted
    April 25, 2015
    Terminated
    June 1, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.

    Reason

    Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).

    Action

    On 3/10/2015, URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2015-047, dated 3/10/2015) were sent to users notifying them of the issue and advising them of the required actions. Customers are to complete and return the Confirmation of Receipt no later than March 23, 2015. The firm is currently working on a resolution and will issue a follow up notification upon the software's availability. For questions, please contact Customer Technical Services at 1-800-421-3311.

    Distribution

    Worldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

    Quantity

    VITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152