BEUDAMED
    FDA Recall Open, Classified

    Access Total T4 Calibrator, Catalog No. 33805

    Recall: Z-1922-2026 · Initiated March 16, 2026

    Recall

    Recall Number
    Z-1922-2026
    Event Number
    98591
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    KLI
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 16, 2026
    Posted
    April 22, 2026
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    Access Total T4 Calibrator, Catalog No. 33805

    Reason

    Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

    Action

    Pending

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen.

    Quantity

    2068 US, 2830 OUS