CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Feb 22, 2007
Report 2018433-2007-00010 · MDR key 953209
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Manufacturing, 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 SHE RECEIVED ASPARTATE AMINOTRANSFERASE ACTIVATED (AST-A) REAGENTS THAT WERE LABELED INCORRECTLY. THE AST-A REAGENTS ARE LABELED AS "ALT-A" BUT THE BARCODE IS LABELED CORRECTLY AS AST-A. THE CUSTOMER STATED THAT SHE CAN USE THE REAGENTS BUT THE LABELING IS INCORRECT. THERE IS 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.