Z-0786-2024 Class II Ongoing
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
- 16 units
Product Description
REV 2 Flowcell Capsule Spare, Part Number: C04154
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
UDI/DI15099590689452, All lot numbers