BEUDAMED
    FDA Recall Open, Classified

    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    Recall: Z-0777-2023 · Initiated November 18, 2022

    Recall

    Recall Number
    Z-0777-2023
    Event Number
    91175
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    JJW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 18, 2022
    Posted
    January 3, 2023
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500

    Description

    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    Reason

    Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

    Action

    The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2022 by mail and email. The notice explained the problem and requested the following actions be taken: "If IRISpec CB controls pass (QC results are within QC acceptance criteria): Continue to process patient samples per IFU (P/N 301-7146BE) If IRISpec CB controls fail (QC results are outside QC acceptance criteria): Refer to Addendum A below for troubleshooting No retrospective review of QC or patient sample results is necessary." "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 listed above to another laboratory, please provide them a copy of this letter."

    Distribution

    US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

    Quantity

    3657 units