BEUDAMED
    FDA Recall Open, Classified

    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    Recall: Z-0984-2022 · Initiated February 16, 2022

    Recall

    Recall Number
    Z-0984-2022
    Event Number
    89655
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    JJW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 16, 2022
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500

    Description

    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    Reason

    IRISpec CA failures for glucose.

    Action

    The recall letter was issued via email on 2/17/2022 and by first class mail on 2/18/2022 for U.S. consignees. The letter explained the issue, the impact of the issue, and the actions to be taken by the consignee. The consignee was to update the quality control QC ranges for glucose as instructed in the letter. The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification. As an interim action, a lower limit on the glucose control range was being implemented via the notification. The letter was to serve as a labeling update for the issue until further notice. The information was to be shared with the consignee's laboratory staff and retained as part of the laboratory Quality System documentation. If the product has been forwarded to another laboratory, the consignee is to provide them a copy of the letter. The consignee was requested to respond to the notification electronically or manually within 10 days. A response form was enclosed for completion and return. Also enclosed was an addendum which provided instructions for updating the QC ranges for glucose in the analyzer. OUS consignees were notified via email and first class USPS beginning 2/16/2022.

    Distribution

    Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

    Quantity

    12,306 kits