MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received May 11, 2007 · Event occurred Mar 26, 2007
Report 2018433-2007-00020 · MDR key 967378
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Laboratories, 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 (ASTA) REAGENT IS MISLABELED. THE CUSTOMER STATES THAT ON THE BOX AND ON THE SIDE OF THE REAGENT IT READS AST-A BUT ON THE TOP OF THE BOTTLE IT READS ALTA. THERE WAS 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.
Remedial action
- Notification