CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Mar 6, 2007
Report 2018433-2007-00011 · MDR key 953213
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
8D37-30
Lot number
46059HW0010
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 (AST-A) REAGENT BOTTLE IS LABELED BOTH AST-A AND ALT, THE BARCODE IS CORRECTLY LABELED AST-A. THE CUSTOMER STATED THAT THE BOTTLES CAN BE USED BUT THE LABELING IS INCORRECT, THEREFORE, THEY WILL REMOVE THE ALT-A LABEL TO AVOID CONFUSION IN THE LABORATORY. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.