Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Reported: February 12, 2025 Initiated: January 3, 2024 #Z-1115-2025
Product Description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 61 units
- Distribution
- 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.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument. Recalled by Beckman Coulter, Inc.. Units affected: 61 units.
Why was this product recalled? ▼
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2025. Severity: Moderate. Recall number: Z-1115-2025.
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