MalfunctionCFJ
SYNCHRON LD ENZYMES KIT
Received Dec 10, 2010 · Event occurred Nov 18, 2010
Report 2050012-2010-01641 · MDR key 1918973
Device
Generic name
Ld Enzymes Kit
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
476841
Lot number
Z911034
Product problems
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT LACTATE DEHYDROGENASE (LD) CARTRIDGE WAS MISSING REAGENT IN ONE COMPARTMENT. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT REPLACEMENT.
Remedial action
- Replace