[pending] DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for
Pending LLM rewrite. Source: FDA_DEVICE Z-1529-2025.
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
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
- 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 (20)
- UDI-DI 15099590732103 Serial/Lot Numbers: 300116
- 300117
- 300118
- 300123
- 300126
- 300128
- 300129
- 300130
- 300131
- 300133
- 300134
- 300135
- 300136
- 300137
- 300138
- 300139
- 300141
- 300142
- 300143
- 300145
Distribution
Distribution scope not specified by the agency.
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