MalfunctionCKA
SYNCHRON CX/LX ALT REAGENT KIT
Received Apr 4, 2011 · Event occurred Mar 2, 2011
Report 2050012-2011-00945 · MDR key 2037888
Device
Generic name
Cx/lx Alt Reagent Kit
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
476826
Lot number
Z010032
Product problems
- Break
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS PROVIDED WITH NEW REAGENT. NO SERVICE WAS PERFORMED.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE BOTTOM OF SYNCHRON CX/LX ALT REAGENT BOTTLE WAS DAMAGED LEADING TO LEAKAGE. NO INJURY WAS REPORTED FOR THIS EVENT.
Remedial action
- Replace