[pending] DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Pending LLM rewrite. Source: FDA_DEVICE Z-1913-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
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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