REV 2 Flowcell Capsule Spare, Part Number: C04154
FDA Recall #Z-0786-2024 — Class II — December 19, 2023
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.
Recalling Firm
Beckman Coulter, Inc. — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
16 units
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,
Code Information
UDI/DI15099590689452, All lot numbers
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated