BEUDAMED
    FDA Recall Terminated

    Coag-A-Mate MTX and MTX II Instrument Operator Manual

    Recall: Z-0771-04 · Initiated September 29, 2003

    Recall

    Recall Number
    Z-0771-04
    Event Number
    28595
    Firm
    Biomerieux, Inc.
    FEI Number
    1039284
    Product Code
    GKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2003
    Posted
    July 20, 2004
    Terminated
    June 8, 2005
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    Coag-A-Mate MTX and MTX II Instrument Operator Manual

    Reason

    Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.

    Action

    Consignees were notified by letter on September 29, 2003.

    Distribution

    Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, HK, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, N. Zealand, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, UK.

    Quantity

    unknown