BEUDAMED
    FDA Recall Open, Classified

    Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

    Recall: Z-2145-2023 · Initiated June 2, 2023

    Recall

    Recall Number
    Z-2145-2023
    Event Number
    92484
    Firm
    Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany
    FEI Number
    3006677029
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 2, 2023
    Posted
    July 14, 2023

    Description

    Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

    Reason

    A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

    Action

    On 06/12/2023, Beckman Coulter issued an Urgent Medical Device Recall Notification to affected consignees. Beckman Coulter asked consignees to take the following actions: 1. Inspect tubes routed to error regions and confirm that the tube type was appropriate per the assay IFU for the test performed. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email./" Manually, complete and return the enclosed Response Form. 4. If you have any questions regarding this notice, please contact our Customer Support Center or your local Beckman Coulter Representative: " From our website: http://www.beckmancoulter.com/" By phone: call 1-800-526-3821 in the United States. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,

    Quantity

    15