MalfunctionCKA
ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM.
Received Aug 5, 2011 · Event occurred Jul 12, 2011
Report 2050012-2011-03903 · MDR key 2194014
Device
Generic name
Alanine Amino Transferase (alt/sgpt) Test System
Manufacturer
Beckman Coulter Inc.Model number
ALT REAGENTCatalog number
442620
Lot number
M012323
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REPLACEMENT ALT REAGENT WAS SENT TO THE CUSTOMER. BEC INTERNAL IDENTIFICATION NUMBER IS (B)(4).
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT ALANINE AMINO TRANSFERASE (ALT) REAGENT LEAKED FROM THE BOTTOM CARTRIDGE. NO INJURY WAS REPORTED.