Official recall record

Access Total T4 Calibrator, Catalog No. 33805

US FDA — Medical Devices · 2026-03-16 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Alert date: 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.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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