Reported Sep 25, 2024 · Ongoing
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF…
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?
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
- Lot codes and dates
- UDI/DI 15099590230623
- Serial Numbers
170 of 170 codes
300116300117300118300123300126300128300129300130300131300133300134300135300136300137300138300139300141300142300143300145300147300148300149300150300151300152300153300154300155300156300157300158300160300161300162300163300164300166300167300168300169300170300171300172300174300176300178300179300180300181300182300183300188300189300190300192300193300194300195300196
- Amount recalled
- 170 units
Where it was sold
- Nationwide
Why it was recalled
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.
This product could cause temporary or reversible health problems — stop using it.
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