Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0265-2025 — Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Sys

U.S. FDA — Device Enforcement · United States · 2024-09-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0265-2025
Date of alert: 2024-09-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15099590202910

Reported risk: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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