Beckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving inaccurate laboratory results that could cause patient harm through unnecessary testing, delayed treatment for thyroid disorders, and incorrect medication dosing. Although no illnesses have been reported, the hazard directly threatens patient safety with documented risk of serious clinical harm.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Total T4 Calibrator (Catalog No. 33805) lots 538729, 538815, 538898, 539107, and 539243. The recalled calibrators exhibit a negative bias and slopes outside product specifications on DxI 600/800 instruments, causing false low patient test results.
The inaccurate results can lead to serious clinical consequences. Patients may undergo unnecessary additional diagnostic testing, be treated for disorders they do not have, or experience delayed treatment for hyperthyroidism. For pregnant patients being monitored for thyroid hormone supplementation, incorrect treatment or dose may be administered. Delayed results could also necessitate repeat blood draws with associated complications.
The product has been distributed worldwide to the United States and internationally to Argentina, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Canada, China, Côte d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, 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, Thailand, Turkey, United Arab Emirates, Uzbekistan, Vietnam, and Yemen.
Affected customers should contact Beckman Coulter regarding return of the recalled calibrator lots.
The recalled product
- Product
- Access Total T4 Calibrator, Catalog No. 33805
- Manufacturer
- Beckman Coulter, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI 15099590225872 Lots 538729
- 538815
- 538898
- 539107
- 539243
Distribution
Distributed nationwide across the United States.
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