Reported Mar 19, 2025 · Ongoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
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 AnalyzerCatalog Number C11137
- Lot codes and dates
- UDI-DI15099590732103
- Serial Numbers
245 of 245 codes
300116300117300123300124300126300128300129300130300131300132300133300134300135300136300137300138300139300141300142300143300144300145300147300148300149300150300151300152300153300154300155300156300157300158300161300162300163300164300166300167300168300169300170300171300172300173300174300176300177300178300179300181300182300183300186300188300189300190300191300192
- Amount recalled
- 245 units
Where it was sold
- Nationwide
Why it was recalled
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
This product could cause temporary or reversible health problems — stop using it.
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