FDA recall, , Moderate risk
Beckman Coulter Access Total T4 Calibrator
The Access Total T4 Calibrator shows a negative bias on DxI 600/800 instruments, with slopes outside specifications.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc. of Chaska, Minnesota, is recalling the Access Total T4 Calibrator, Catalog No. 33805, because lots 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, and a patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. The company began the recall on March 16, 2026, and the FDA added it to the Enforcement Report on April 22, 2026.
The recall affects distribution nationwide in the U.S. and worldwide, including countries such as Argentina, Canada, China, Germany, India, Japan, Mexico, and the United Arab Emirates.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Access Total T4 Calibrator, Catalog No. 33805
- UDI-DI
- 15099590225872
- Lot code
- 538729
- 538815
- 538898
- 539107
- 539243
Recall details
- Company began the recall
- Sold in
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.
- Company
- Beckman Coulter, Inc.Chaska, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98591
- Recall number
- Z-1922-2026
- Quantity recalled
- 2068 US, 2830 OUS
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
