BEUDAMED
    FDA Recall Terminated

    enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

    Recall: Z-0914-2012 · Initiated April 28, 2011

    Recall

    Recall Number
    Z-0914-2012
    Event Number
    60893
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 28, 2011
    Posted
    January 26, 2012
    Terminated
    July 2, 2018
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626

    Description

    enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

    Reason

    Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems.

    Action

    Ortho-Clinical Diagnostics sent an Urgent Product Correction Notification letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to post the enclosed attachment near their centrifuge as a reference. Clean and carefully inspect the suspension groove area of the centrifuge buckets for cracks as part of their weekly maintenance procedure. Careful to check for micro-cracks that may not be easily detectable. If any cracks/micro-cracks, corrosion or damage are present, they must immediately discontinue using the centrifuge and contact OCD Customer Technical Services at 1-800-421-3311 to obtain replacements. OCD recommends that they do not exceed the manufacturer's relative centrifuge force (RCF) and run time limits for the blood collection devices used by their laboratory. Complete and return the attached Confirmation of Receipt Form. For questions regarding this recall call the Customer Service Center at 1-800-421-3311. .

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.

    Quantity

    78 units worldwide (18 Domestic and 68 Foreign)