MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received May 11, 2007 · Event occurred Mar 20, 2007
Report 2018433-2007-00021 · MDR key 967371
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 SHE RECEIVED THE ASPARTATE AMINOTRANSFERASE ACTIVATED (ASTA) REAGENT AND FOUND CONFLICTING LABELING AND IS QUESTIONING WHICH LABEL IS CORRECT. ALTA OR ASTA? 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