ENZYMATIC ALT REAGENT KIT
Received Jan 26, 2011 · Event occurred Jan 5, 2011
Report 2050012-2011-00233 · MDR key 1971089
Device
Generic name
Alanine Amino Transferase Reagent
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
476826
Lot number
Z006019
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER. INSTRUMENT/DEVICE NOT INVOLVED.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ALANINE AMINO TRANSFERASE (ALT) CARTRIDGE LEAK. NO INJURY WAS REPORTED.
Remedial action
- Replace