BEUDAMED
    FDA Recall Terminated

    Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)

    Recall: Z-0199-2007 · Initiated October 2, 2006

    Recall

    Recall Number
    Z-0199-2007
    Event Number
    36597
    Firm
    Dako Colorado, Inc.
    FEI Number
    3004485389
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 2, 2006
    Posted
    November 21, 2006
    Terminated
    February 1, 2007
    Address
    4850 Innovation Dr, Fort Collins, CO, 80525-5576

    Description

    Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)

    Reason

    Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.

    Action

    Consignees were notified by phone on 10/02/2006 and later by letter on 10/20/2006. They were given the option of using the stainer as 'Research Use Only' or having the stainer returned to Dako.

    Distribution

    Worldwide distribution --- USA including states of CA, IN, NC, WA and countries of Denmark, France, Germany, and Spain.

    Quantity

    11 units