BEUDAMED
    FDA Recall Terminated

    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.

    Recall: Z-1341-2018 · Initiated January 29, 2018

    Recall

    Recall Number
    Z-1341-2018
    Event Number
    79381
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    OYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 29, 2018
    Terminated
    June 27, 2019
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.

    Reason

    The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.

    Action

    The recalling firm issued letters dated 1/25/2018 via email on 1/31/2018 or to some customers via regular mail during the week of 1/29/2018.

    Distribution

    Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.

    Quantity

    288 devices