DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reported: June 11, 2025 Initiated: April 23, 2025 #Z-1913-2025
Product Description
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reason for Recall
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 231 units
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d'lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20. Recalled by Beckman Coulter, Inc.. Units affected: 231 units.
Why was this product recalled? ▼
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Moderate. Recall number: Z-1913-2025.
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