The Recall Desk
HighFDA (Devices)·Z-1926-2025·Announced 2025-06-18

DxI 9000 Immunoassay Analyzer Recall Due to Incorrect Motor Installation

Beckman Coulter is recalling 324 units of the DxI 9000 Access Immunoassay Analyzer due to incorrect motor and cable installation that causes error codes, preventing test performance and delaying results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product where no injuries or illnesses have been reported. The equipment malfunction prevents diagnostic tests from being performed and delays critical results, which could impact patient care, but the source text contains no reports of actual patient harm.

Plain-English summary

Beckman Coulter, Inc. is recalling 324 units of the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137, software version 1.20) due to incorrect installation of a motor, encoder, and cable. The incorrect installation introduces error codes that prevent the device from performing assays and delay the generation of test results. Field service may be required to resolve the issue.

The affected analyzers were distributed worldwide to healthcare facilities in the United States and over 30 other countries, including Italy, Germany, Spain, France, Australia, Brazil, and the United Kingdom. Affected units have serial numbers starting at 300141.

The recalled product

Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Diagnostic Equipment
Hazard
  • device-malfunction
  • diagnostic-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 15099590732103

Distribution

Distributed nationwide across the United States.

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