DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Reported: June 18, 2025 Initiated: April 23, 2025 #Z-1926-2025
Product Description
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Reason for Recall
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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
- 324 units
- Distribution
- Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia, Kazakhstan, Cote d'lvoire, Poland, Korea, Republic of, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20. Recalled by Beckman Coulter, Inc.. Units affected: 324 units.
Why was this product recalled? ▼
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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 18, 2025. Severity: Moderate. Recall number: Z-1926-2025.
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