MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received May 11, 2007 · Event occurred Mar 26, 2007
Report 2018433-2007-00025 · MDR key 967165
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Mfg, IncModel number
NACatalog number
8D37-30
Lot number
46059HW00
Product problems
- Mislabeled
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER STATED THAT, THE ASPARTATE AMINOTRANSFERASE ACTIVATED (ASTA) REAGENT IS LABELED AS ASTA. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Remedial action
- Notification