BEUDAMED
    FDA Recall Terminated

    Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

    Recall: Z-0299-04 · Initiated December 3, 2003

    Recall

    Recall Number
    Z-0299-04
    Event Number
    27915
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    DHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 3, 2003
    Posted
    January 6, 2004
    Terminated
    February 20, 2004
    Address
    100 Indigo Creek Drive, Rochester, NY, 14650-0881

    Description

    Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

    Reason

    Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

    Action

    U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.

    Distribution

    154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.

    Quantity

    524 reagent packs