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

Recall Z-0216-2026 — DxI 9000 Access Immunoassay Analyzer, Part Number C11137

U.S. FDA — Device Enforcement · United States · 2025-09-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0216-2026
Date of alert
2025-09-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590732103
Reported risk: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.