BEUDAMED
    FDA Recall Terminated

    Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed).

    Recall: Z-1051-04 · Initiated March 12, 2004

    Recall

    Recall Number
    Z-1051-04
    Event Number
    29444
    Firm
    Bayer Healthcare LLC 1884 Miles Ave Buildings 110 (Adlake), 17 & 18 Elkhart IN 46514-2291
    FEI Number
    1810909
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 12, 2004
    Posted
    July 20, 2004
    Terminated
    September 14, 2004

    Description

    Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed).

    Reason

    Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.

    Action

    Consignees were notified by recall letter on or about March 12, 2003 requesting customers to return their units for inspection and rework.

    Distribution

    United States, Australia, Canada, France, Germany, India, Japan, Netherlands, Poland, South Korea, Sweden, Switzerland and United Kingdom.

    Quantity

    424