MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received May 11, 2007 · Event occurred Mar 21, 2007
Report 2018433-2007-00024 · MDR key 967151
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 WITH THE LOT# 46059HW00 IS LABELED ALTA BUT THE BARCODE IS READING THE REAGENT AS 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