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Completed

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

FDA Recall Z-1115-2025 · Posted 2025-02-06

Recalling FirmBeckman Coulter, Inc.
Recall StatusCompleted
Product CodeJJE
Date Initiated2024-01-03
Product Quantity61 units

Reason for Recall

A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

Firm Action

A field service engineer was dispatched to the customer site to perform the software update and to replace the PCB TSI-RSI board from 01/03/2024 through 12/26/2024.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. · 2022-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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