MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received May 11, 2007 · Event occurred Mar 19, 2007
Report 2018433-2007-00019 · MDR key 967387
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
Description of Event or Problem
THE CUSTOMER STATED THAT THE ASPARTATE AMINOTRANSFERASE ACTIVATED (ASTA) REAGENT IS LABELED INCORRECTLY, IT IS LABELED AS ALT-A INSTEAD OF AST-A. 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