Z-0784-2024 Class II Ongoing

Recalled by Beckman Coulter, Inc. — Miami, FL

Recall Details

Product Type
Devices
Report Date
January 31, 2024
Initiation Date
December 19, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
254 units

Product Description

Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947

Reason for Recall

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

Distribution Pattern

US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland,

Code Information

C49513, UDI/DI 15099590748647; C76947, UDI/DI 15099590748654; All serial numbers