DxI 9000 Access Immunoassay Analyzer software version 1.20 recall
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to incorrect motor/encoder and cable installation that causes error codes, prevents assays from running, and delays result generation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a functional defect (error codes, result delays) rather than direct health risk, and the source explicitly indicates the issue may require field service without stating confirmed harm.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20. The recall affects 324 units with specific serial numbers that were manufactured starting with serial number 300141.
A new motor/encoder and cable was incorrectly installed in these instruments. This installation error introduces error codes that prevent the assay from being performed and cause delays in result generation.
The affected devices have been distributed worldwide, including to the United States and internationally to Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, the Province of China, India, the United Kingdom, Hungary, Austria, Portugal, Croatia, Kazakhstan, Côte d'Ivoire, Poland, the Republic of Korea, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.
Healthcare facilities and laboratories using affected units should contact Beckman Coulter for field service to resolve the delay in results generation.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- installation-defect
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15099590732103
Distribution
Distributed nationwide across the United States.
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