CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Feb 27, 2007
Report 2018433-2007-00008 · MDR key 953200
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 ASPARTATE AMINOTRANSFERASE ACTIVATED (AST-A) REAGENT BOTTLES (LIST 8D37-30; LOT 46059HW00) ARE LABELED INCORRECTLY. ON THE TOP OF THE BOTTLES ARE LABELED ALT-A AND ON THE FRONT OF THE BOTTLES THE LABEL IS CORRECT WITH AST-A. WHEN THE CUSTOMER SCANS THE REAGENTS, THE BOTTLES ARE RECOGNIZED AS AST-A. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.