BEUDAMED
    FDA Recall Open, Classified

    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

    Recall: Z-1606-2023 · Initiated April 5, 2023

    Recall

    Recall Number
    Z-1606-2023
    Event Number
    92071
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KHS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 5, 2023
    Posted
    May 18, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

    Reason

    There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

    Action

    On April 5, 2023, Beckman Coulter (BEC) issued a "URGENT MEDICAL DEVICE RECALL" Notification via mail and/or E-Mail. In addition, to informing consignees about the recalled product, BEC asked consignees to take the following actions: 1. Safely dispose of the Bicarbonate lot numbers that are specifically described in Table A. 2. If replacement or re-imbursement of the above lots is required, customers are directed to contact their local Beckman Coulter representative for replacement and re-imbursement. 3. Customers are advised to implement the adjusted Calibration OD range using the instructions within the customer letter to avoid generation of elevated results for all other Bicarbonate lots. 4. Retrospective review of patient data is not required due to the remote possibility of generating falsely elevated, clinically impactful results which could cause a change in treatment. Please share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forward any of the affected products(s) listed above to another laboratory, please provide them a copy of the letter. 5. Please respond within 10 days in one of the following ways: - Electronically, you received this communication via email. - Manually, complete and return the enclosed Response Form. 6. If you have any questions, please call 1-800-854-3633

    Distribution

    Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,

    Quantity

    48,633 units in total