BEUDAMED
    FDA Recall Terminated

    AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.

    Recall: Z-1151-2018 · Initiated January 18, 2018

    Recall

    Recall Number
    Z-1151-2018
    Event Number
    78999
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 18, 2018
    Terminated
    September 27, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.

    Reason

    A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.

    Action

    A recall notification letter was sent to affected US consignees on 1/19/2018 notifying them of the issue. In addition, the recalling firm is instructing field service engineers to inspect the tip present sensor for misalignment at the next service visit.

    Distribution

    Worldwide distribution. US nationwide, Algeria, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    73 units in US