CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Mar 8, 2007
Report 2018433-2007-00013 · MDR key 953224
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 STATED THAT THE ASPARTATE AMINOTRANSFERASE ACTIVATED (AST-A) IS LABELED ON THE SIDE OF THE REAGENT BOTTLES AND THE BARCODE IDENTIFICATION ALSO IS LABELED AST-A BUT THE LABEL ON THE TOP SECTION OF THE CARTRIDGE IS LABELED ALT-A. THE CUSTOMER STATED THAT THE BOTTLES COULD BE USED BECAUSE THE BARCODE IDENTIFICATION IS CORRECT FOR AST-A AND ONLY THE TOP LABEL IS INCORRECT. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS THE INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.