Official recall record
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-06-25
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590369231
- Brand on record
- Beckman Coulter, Inc.
What the authority reported
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
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.
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
All 32 official recall notices naming Beckman Coulter, Inc. on this site →