Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reported: July 31, 2024 Initiated: June 4, 2024 #Z-2414-2024
Product Description
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reason for Recall
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 143 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.. Recalled by Beckman Coulter, Inc.. Units affected: 143 devices.
Why was this product recalled? ▼
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2024. Severity: Moderate. Recall number: Z-2414-2024.
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