MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Mar 1, 2007
Report 2018433-2007-00017 · MDR key 953249
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
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
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.