MalfunctionCKA
SYNCHRON ASPARTATE AMINOTRANSFERASE KIT
Received Jun 20, 2011 · Event occurred May 23, 2011
Report 2050012-2011-02279 · MDR key 2134552
Device
Generic name
Ast Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
476831
Lot number
M012316
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT AN ASPARTATE AMINOTRANSFERASE (AST) CARTRIDGE WAS LEAKING FROM THE BOTTOM SEAM.NO INJURY WAS REPORTED ON THIS ISSUE.
Additional Manufacturer Narrative
(B)(4)
Remedial action
- Replace