MalfunctionCKA
SYNCHRON CX ALT REAGENT KIT
Received May 26, 2011 · Event occurred Apr 28, 2011
Report 2050012-2011-01914 · MDR key 2104390
Device
Generic name
Alanine Aminotransferase Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
442620
Lot number
M012323
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DISTRIBUTOR REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE BOTTOM OF SYNCHRON CX ALT REAGENT CARTRIDGE WAS LEAKING THROUGH THE SEAM. NO INJURY WAS REPORTED FOR THIS EVENT.
Additional Manufacturer Narrative
PRODUCT WAS QUARANTINED.