FDA recall Z-0786-2024

Beckman Coulter, Inc. · Class II · device

Product

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

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,

Key facts

Status
Ongoing
Initiation date
2023-12-19
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2024