CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Feb 20, 2007
Report 2018433-2007-00012 · MDR key 953220
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 THEY ORDERED ASPARTATE AMINOTRANSFERASE ACTIVATED (AST-A) REAGENT AND IT WAS LABELED INCORRECTLY AS ALT-A. THE CUSTOMER STATED THAT THE BARCODE IS ALSO LABELED AST-A AND WHEN SCANNED THE INSTRUMENT RECOGNIZES THE AST-A ASSAY. THE CUSTOMER STATED THEY WILL CROSS OUT ALT-A AND WRITE AST-A ON THE BOTTLES. 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.