DxI 9000 Access Immunoassay Analyzer Software Update Error Codes
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.20 because the update introduces error codes that prevent assays from being performed and may delay result generation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a software malfunction causing delays and operational errors, which is a functional defect rather than a safety hazard that causes or risks causing harm to patients. The issue is correctable through field service and does not meet criteria for High or above.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137) running software version 1.20. The software update introduces error codes that prevent the assay from being performed and cause delays in result generation.
The issue may require field service to resolve the delay. A total of 231 units have been distributed worldwide, including to the United States and internationally to Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Ireland, Oman, Algeria, Czechia, Korea, Slovakia, Côte d'Ivoire, Australia, Ireland, New Zealand, Austria, Hungary, Brazil, Israel, and Portugal.
Healthcare facilities and laboratories using affected units should contact Beckman Coulter for assistance. Specific serial numbers and the UDI-DI (15099590732103) have been identified for the affected devices.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 231
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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