BEUDAMED
    FDA Recall Terminated

    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.

    Recall: Z-1473-04 · Initiated July 28, 2004

    Recall

    Recall Number
    Z-1473-04
    Event Number
    29887
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    DCK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2004
    Posted
    September 18, 2004
    Terminated
    June 9, 2005
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.

    Reason

    The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

    Action

    Letters dated 7/28/2004. Distributors instructed to destroy product. Users instructed to use revised IR wash tolerance values (provided with letter). A Calibration Diskette, Data Release Version 5384 will also be provided to end users.

    Distribution

    DOMESTIC distribution (nationwide): Product shipped to 6 distributors, 140 hospitals, and 6 U.S. government accounts. FOREIGN distribution: Product shipped to 22 Ortho-Clinical/J&J affiliates in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. The foreign affiliates further distributed product.

    Quantity

    Cat 192 6740 - 5,912 cartons x 250 slides; Cat #809 7990 - 10,344 x 90 slides