- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243
- Units affected
- 2068 US, 2830 OUS
- Distribution pattern
- 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.
- Firm location
- Chaska, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1922-2026
- Recall initiated
- March 16, 2026
- FDA classification date
- April 22, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98591
- Last updated on HTM Vibe
- July 24, 2026