BEUDAMED
    FDA Recall Terminated

    Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.

    Recall: Z-0869-03 · Initiated February 27, 2003

    Recall

    Recall Number
    Z-0869-03
    Event Number
    25850
    Firm
    Tecan U S Inc
    FEI Number
    1037985
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2003
    Posted
    May 29, 2003
    Terminated
    April 6, 2006
    Address
    4022 Stirrup Creek Rd, Ste310, Durham, NC, 27709

    Description

    Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.

    Reason

    Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.

    Action

    Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.

    Distribution

    Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .

    Quantity

    327 instruments require firmware upgrade.