Beckman Coulter DxU Analyzers Recalled for Potential Rust-Related Diagnostic Errors
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
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 an FDA Class II recall without reported illnesses or injuries. The hazard—potential rust causing erroneous diagnostic results—is theoretical and has not resulted in confirmed adverse events. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxU 850m/840m Microscopy Analyzers, Part Numbers C49513 and C76947. All serial numbers of these analyzers are included in the recall.
The cannula, a component in the Flowcell and iQClear Rinse Waste Well Assembly, may rust over time. Rust formation has the potential to generate erroneous results in test analysis.
The recall affects 254 units that have been distributed in the United States and internationally, including Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, and the United Kingdom.
The recalled product
- Product
- Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- rust
- erroneous-results
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 (5)
- C49513
- UDI/DI 15099590748647
- C76947
- UDI/DI 15099590748654
- All serial numbers
Distribution
Distribution scope not specified by the agency.
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