Reported Apr 16, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative,…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI 15099590732103
- Serial/Lot Numbers
300116300117300118300123300126300128300129300130300131300133300134300135300136300137300138300139300141300142300143300145300147300148300149300150300151300152300153300154300155and 300156
- Amount recalled
- 30 OUS
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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