MalfunctionCKA
SYNCHRON® CONTROL MULTI-LEVEL 6X20M
Received Jan 7, 2011 · Event occurred Dec 8, 2010
Report 2050012-2011-00074 · MDR key 1951815
Device
Generic name
Control Multi-level
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
657365
Lot number
M909750
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A CREDIT MEMO WAS ISSUED TO THE CUSTOMER.
Description of Event or Problem
IT WAS DISCOVERED IN THE BECKMAN COULTER INC. (BCI) WAREHOUSE THAT THE SYNCHRON CONTROL MULTI-LEVEL 6X20M CHEMISTRY REAGENT LEAKED. NO INJURY WAS REPORTED.