Official recall record
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-07-10
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590230623
- Brand on record
- Beckman Coulter, Inc.
What the authority reported
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.
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.
Same barcode in other registries
The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-11-21 · US FDA — Medical Devices
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 - 2024-04-18 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Other recalls from this brand
- 2026-03-16 · US FDA — Medical Devices
Access Total T4 Calibrator, Catalog No. 33805 - 2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin S