Beckman Coulter DxI 9000 Analyzer Communication Failure Recall
Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.
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 medical device with no reported illnesses or injuries. The recall addresses a potential communication failure in laboratory equipment that could delay result reporting; the absence of reported harm and the operational nature of the issue support a Moderate classification.
Plain-English summary
Beckman Coulter is recalling 80 units of the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137 with TSI/RSI firmware version 1.1.0.0). These analyzers have been distributed worldwide, with identified units in Florida, Texas, and Washington.
The recalled analyzers contain tip stocker interface (TSI) and reagent storage interface (RSI) boards with firmware version 1.1.0.0 that can cause sub-system communication failures. Such failures could result in delays in reporting patient results.
Healthcare facilities should verify whether they have any of the affected serial numbers and contact Beckman Coulter to determine appropriate remediation steps.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- communication-failure
- firmware-issue
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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