Beckman Coulter DxI 9000 Access Immunoassay Analyzer communication loss
Beckman Coulter DxI 9000 Access Immunoassay Analyzer may lose connection to laboratory information systems, interrupting sample processing and delaying patient test results.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a communication/processing delay that may delay patient treatment, but the source explicitly describes the risk without evidence of actual patient harm occurring.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer due to a communication fault. When the analyzer is connected to a host system (such as a laboratory information system or middleware) and has accumulated canceled QC test results that were not sent by the host system, the analyzer may lose communication with that host system.
When communication is lost, sample processing is interrupted. This delays the reporting of patient test results and may subsequently delay patient treatment. Approximately 370 units have been distributed worldwide.
Healthcare facilities using this analyzer should contact Beckman Coulter, Inc. for guidance on a software update to address this issue.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 370
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 (2)
- UDI/DI 15099590732103
- all units run with system software versions SW 1.20.0 and below
Distribution
Distribution scope not specified by the agency.
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