Z-0784-2024 Class II Ongoing
FDA device recall Z-0784-2024 was initiated by Beckman Coulter, Inc. on December 19, 2023 and is designated Class II. 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 res… The recall status is ongoing. Affected quantity: 254 units.
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