MalfunctionCKA
SYNCHRON LX ISE REFERENCE REAGENT
Received Jan 3, 2011 · Event occurred Nov 30, 2010
Report 2050012-2011-00026 · MDR key 1945113
Device
Generic name
General Purpose Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
A28937 (FOR THE REAGENT)
Lot number
M009428
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT A REPLACEMENT.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING AN ISE REFERENCE BOTTLE WAS RECEIVED LEAKING. NO INJURY WAS REPORTED.
Remedial action
- Replace