DxI 9000 Analyzer Recalled for Electrical Short Risk on PCB Boards
Beckman Coulter recalls the DxI 9000 immunoassay analyzer due to ground screws that may cause electrical shorts, potentially generating smoke and delaying patient test results.
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 is a Class II FDA recall of a medical device with a theoretical electrical hazard (ground screws causing shorts and smoke) affecting diagnostic functionality and user safety. No injuries or illnesses have been reported, placing this in the High category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
The FDA has issued a recall of Beckman Coulter's DxI 9000 Access Immunoassay Analyzer (catalog number C11137), an in vitro diagnostic device used to measure various analyte concentrations in human body fluids for quantitative, semi-quantitative, or qualitative analysis. Thirty units were distributed internationally to Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and the United Kingdom.
Ground screws on the device's PCB boards may cause electrical shorts. This defect can lead to smoke generation, which poses a hazard to both equipment and users. The electrical malfunction may also cause delays in patient test results.
Healthcare facilities outside the United States using affected lot numbers should verify whether their devices are part of this recall and contact the manufacturer for guidance on remediation options.
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.
- Hazard
- electrical-short
- smoke
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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