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

Recall Z-3180-2024 — Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument

U.S. FDA — Device Enforcement · United States · 2024-07-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3180-2024
Date of alert
2024-07-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590230623
Reported risk: Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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