Z-0787-2024 Class II Ongoing
FDA device recall Z-0787-2024 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: 2 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
- 2 units
Product Description
iQ Waste Well Adapter, Part Number: 700-3393
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/DI 15099590706180, all lot numbers