MalfunctionCKA
SYNCHRON® CX AST REAGENT KIT
Received May 3, 2011 · Event occurred Apr 5, 2011
Report 2050012-2011-01391 · MDR key 2075817
Device
Generic name
Cx Ast Reagent
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
442665
Lot number
T010139
Product problems
- Crack
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 AST REAGENT KIT, WHICH WAS CRACKED OPEN. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.