BEUDAMED
    FDA Recall Terminated

    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

    Recall: Z-1735-2014 · Initiated April 10, 2014

    Recall

    Recall Number
    Z-1735-2014
    Event Number
    68271
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 10, 2014
    Posted
    June 9, 2014
    Terminated
    May 21, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

    Reason

    Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

    Action

    Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.

    Distribution

    Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

    Quantity

    Domestic - 835 units, Foreign - 921 units