Access Total T4 Calibrator
Beckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
Stop using affected lots of Access Total T4 Calibrator, Catalog No. 33805, immediately. Contact Beckman Coulter for instructions on replacement calibrators and verification of patient results obtained with affected lots.
Recall at a glance
- Quantity recalled
- 2068 US, 2830 OUS
Why it was recalled
Beckman Coulter is recalling Access Total T4 Calibrator, Catalog No. 33805, due to negative bias and out-of-specification slopes on DxI 600/800 instruments that may produce falsely low patient results. False low results could lead to unnecessary diagnostic testing, delayed treatment for hyperthyroidism, incorrect thyroid hormone supplementation in pregnant patients, and repeat blood draws.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Access Total T4 Calibrator, Catalog No. 33805
- UDI-DI
- 15099590225872
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification