MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Feb 26, 2007
Report 2018433-2007-00006 · MDR key 953194
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) REAGENT IS LABELED ALT-A ON TOP OF THE BOTTLE. 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.