BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382

    Recall: Z-0307-2014 · Initiated June 12, 2013

    Recall

    Recall Number
    Z-0307-2014
    Event Number
    65572
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    KLT
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 12, 2013
    Posted
    November 15, 2013
    Terminated
    April 11, 2017
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382

    Reason

    Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Action

    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated June 12, 2013, to all affected customers via FedEx regarding Slide Dispense issues with various VITROS Chemistry Product Slides. VITROS ALT, CL-, GGT, LDH, K+, Na+ and TP slides use a different ABP, they are not affected by this issue. OCD provided instructions that may allow their customers to reposition the ABP if a jam occurs. OCD will provide you with a credit for any cartridge where the ABP becomes misaligned within the cartridge body in such a way that you are unable to reposition the ABP successfully to resolve the slide dispense issue. In addition to the Confirmation of Receipt form, OCD also enclosed three (3) copies of a Request for Credit form for you to complete when you require credit for affected cartridges. Complete and return the Confirmation of Receipt by June 21, 2013. If you experience slide dispense condition codes more than once a week, call our Customer Technical Support at 1-800-421-3311. For questions regarding this recall call 585-453-4224.

    Distribution

    Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

    Quantity

    12,484 units (9,040 units domestically & 3,444 units internationally)