BEUDAMED
    FDA Recall Open, Classified

    The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    Recall: Z-0094-2025 · Initiated August 28, 2024

    Recall

    Recall Number
    Z-0094-2025
    Event Number
    95296
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JLW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 28, 2024
    Posted
    October 16, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    Reason

    Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

    Action

    Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via US mail and email. The notice explained the problem, potential impact, requested the discontinuation of use and destruction of the affected product. The notice should be shared with all impacted parties and a retrospective review of patient tests is recommended. For questions regarding this notice, please contact Customer Support Center: . From our website: http://www.beckmancoulter.com . For customers in the United States, if you need replacement product: o Call Client Services at 1-800-854-3633

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.

    Quantity

    2805 units