BEUDAMED
    FDA Recall Open, Classified

    Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

    Recall: Z-2488-2023 · Initiated July 12, 2023

    Recall

    Recall Number
    Z-2488-2023
    Event Number
    92729
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CFN
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    July 12, 2023
    Posted
    August 31, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

    Reason

    Lipemic interference failed to meet the performance specification listed within the IFU.

    Action

    On July 18, 2023 Beckman Coulter issued a "Urgent Medical Device Recall" Notification via email and postal mail. Beckman Coulter asked consignees to take the following action: 1. No retrospective re view of past patient results is required however Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Discontinuance or disposal of this product is not necessary. 3. Per the IFU, avoid highly lipemic samples when using the IgA assay. 4. No update is required to the LIH influences check settings on the analyzer, where in use. 5. Please share this information with your laboratory staff nd 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. 6. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: - Electronically - If you received this communication via email, Manually - complete and return the enclosed Response Form. 7. If you have any questions regarding this notice, please contact our Customer Support Center - www.beckmancoulter.com or 1-800-854-3633 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE NJ NM NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, C¿te d'Ivoire, Croatia, Cura¿ao, Cyprus, Czechia, Denmark, Ecuador, Egypt, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uruguay, Viet Nam, Yemen.

    Quantity

    12,850 units