Beckman Coulter DxI 9000 Analyzer software update prevents assay performance
FDA is recalling Beckman Coulter DxI 9000 Access Immunoassay Analyzers with software version 1.20 due to error codes that prevent assay performance and delay result generation. Field service may be required to resolve the issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a diagnostic analyzer with a functional defect that prevents it from performing its core function. The inability to perform immunoassays creates a risk of harm through delayed or missed diagnoses, which meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
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 device from performing assays and delay the generation of test results.
The recall affects 231 units distributed worldwide, including locations in the United States and over 30 countries. The devices are identified by specific serial numbers provided in the FDA recall notice.
Users of affected devices should contact Beckman Coulter for software updates or service assistance. The manufacturer is working with affected facilities to resolve the issues, which may require field service intervention. Healthcare facilities should verify whether they have affected units by checking the device serial numbers against the FDA recall documentation.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- software-error
- assay-failure
- delayed-results
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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