Official recall record
Access Total T4 Calibrator, Catalog No. 33805
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-03-16
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590225872
- Brand on record
- Beckman Coulter, Inc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima X - 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima X - 2026-08-12 · US FDA — Medical Devices
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
All 39 official recall notices naming Beckman Coulter, Inc. on this site →