FDA Enforcement
Class II
Ongoing
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Recall: Z-0784-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0784-2024
- Event ID
- 93655
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beckman Coulter, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- December 19, 2023
- Classification Date
- January 25, 2024
- Address
- 11800 Sw 147th Ave, N/A, Miami, FL, 33196-2500, United States
Description
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Reason
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.
Code Info
C49513, UDI/DI 15099590748647; C76947, UDI/DI 15099590748654; All serial numbers
Distribution
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,
Quantity
254 units