BEUDAMED
    FDA Recall Open, Classified

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument

    Recall: Z-3180-2024 · Initiated July 10, 2024

    Recall

    Recall Number
    Z-3180-2024
    Event Number
    95156
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 10, 2024
    Posted
    September 19, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument

    Reason

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.

    Action

    Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/10/2024 via US mail and email. The notice explained the problem, impact, and requested the following actions be taken: If your laboratory observes either of these system eventscontact the Beckman Coulter Customer Technical Support Center at 1-800-854-3633 (US and Canada) or your local Beckman Coulter representative (outside US and Canada: a). Chassis.Pneumatics MachineControlStatus(Chassis maintain system air pressure failed. 1.The compressor has failed. 2.A large leak exists in the system) b). Pneumatics Air pressure under limit: ### PSI, Chassis.Pneumatics. WS04CompressedAir.32-35psi.PressureSensor. Beckman Coulter will schedule a time to replace the RSM pneumatic tubing.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

    Quantity

    170 units