BEUDAMED
    FDA Recall Terminated

    Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.

    Recall: Z-1548-2015 · Initiated April 1, 2015

    Recall

    Recall Number
    Z-1548-2015
    Event Number
    70898
    Firm
    Dako North America Inc.
    FEI Number
    2022180
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2015
    Posted
    April 29, 2015
    Terminated
    August 5, 2015
    Address
    6392 Via Real, Carpinteria, CA, 93013-2921

    Description

    Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.

    Reason

    If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request was rejected.

    Action

    Dako sent a Voluntary Product Recall Notification letter starting the week of April 1, 2015 along with a acknowledgement attachment. The letter identified the affected product, problem and actions to be taken. The firm requests that customers inform those in their organization of the notification including organizations where the potentially affected instruments have been transferred. The firm requests that customers complete, sign, and return the acknowledgement form within one week after receiving the notification. For questions contact your Dako sales representative. On 04/29/15 the firm sent out an updated customer notification letter in order to provide additional clarification and instructions to customers in regards to the recall situation.

    Distribution

    Worldwide Distribution - U.S Nationwide in the states of IN and PA and the countries of: Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, UK, and Korea.

    Quantity

    33 (7 in U.S. and 26 Internationally)