BEUDAMED
    FDA Recall Terminated

    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.

    Recall: Z-3135-2017 · Initiated August 21, 2017

    Recall

    Recall Number
    Z-3135-2017
    Event Number
    77997
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    OYE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 21, 2017
    Terminated
    September 27, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.

    Reason

    Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.

    Action

    The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 16, 2017 to the affected customers via email, mail, and phone during the week of August 21, 2017. The letter described the product, problem and actions to be taken. The customers are instructed to follow instructions provided in the letter and complete and return the Customer Response Form within 10 days via Fax to: (786)-639-7500 /7501 /7502 /7504; mail to: Beckman Coulter, Inc.,- Attn: Regulatory Affairs Mail Code 31-B06; 11800 S.W. 147th Avenue; P O BOX 169015, Miami, FL 33116-9015 or email (if received electronically) at: [email protected] -include in subject field: FA-31696 AQUIOS CL August 2017. If you have any questions regarding this notification, please contact: From our website: http://www.beckmancoulter.com By phone: call 800-369-0333 in the United States and Canada. By email: [email protected] Outside the United States and Canada, contact your local Beckman Coulter representative.

    Distribution

    Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia

    Quantity

    213 units (34 units in the US)