MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Feb 28, 2007
Report 2018433-2007-00014 · MDR key 953229
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
8D37-30
Lot number
46059HW00
Product problems
- Mislabeled
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATES THAT THE LABELING OF THE AST-ACTIVATED REAGENT (LIST# 8D37-30 LOT# 46059HW00) IS INCORRECT BUT THE BARCODE IS CORRECT. THE AST-ACTIVATED REAGENT IS INCORRECTLY LABELED AS ALT INSTEAD OF "AST". THE CUSTOMER REMOVED THE WRONG LABEL TO AVOID CONFUSION IN THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.