FDA-Device2024-01-31Class II
REV 2 Flowcell Capsule Spare, Part Number: C04154
Beckman Coulter, Inc.
Hazard
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.
Sold states
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,
Affected count
16 units
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
REV 2 Flowcell Capsule Spare, Part Number: C04154
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief