Beckman Coulter, Inc. recalls Access Total T4 Calibrator

Recalling company

Beckman Coulter, Inc.

Product

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 16, 2026

Reported

Apr 29, 2026

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.

Status

Ongoing

Quantity

2068 US, 2830 OUS

Lot / codes

UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243

Company location

Chaska, MN

Recall type

Voluntary: Firm initiated

Recall number

Z-1922-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1922-2026 in the FDA Enforcement Report. Also see FDA recall press releases.