MalfunctionCKA
SYNCHRON® CX LACTATE DEHYDROGENASE-L (LD) REAGENT KIT
Received May 3, 2011 · Event occurred Apr 5, 2011
Report 2050012-2011-01390 · MDR key 2075818
Device
Generic name
Cx Lactate Dehydrogenase-l (ld) Reagent
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
442655
Lot number
M007474
Product problems
- Break
- Device Damaged Prior to Use
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REPLACEMENT KIT WAS SENT TO THE CUSTOMER.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI), STATING THAT THE CUSTOMER RECEIVED A SYNCHRON CX LACTATE DEHYDROGENASE-L (LD) REAGENT KIT THAT WAS DAMAGED. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.