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
Reported: April 16, 2025 Initiated: July 12, 2024 #Z-1529-2025
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 30 OUS
- Distribution
- OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Beckman Coulter, Inc.. Units affected: 30 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2025. Severity: Moderate. Recall number: Z-1529-2025.
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