HEMOSIL VON WILLEBRAND FACTOR ACTIVITY
Received May 24, 2012 · Event occurred Apr 16, 2012
Report 1217183-2012-00008 · MDR key 2593700
Device
Generic name
Factor Deficiency Test
Manufacturer
Instrumentation Laboratory Co.Model number
NACatalog number
0020004700
Lot number
B11498
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CUSTOMER STATED THEY ARE A REFERENCE LAB USING A STA-R EVOLUTION INSTRUMENT WITH VWF ACTIVITY PART NUMBER 20004700, LOT B11498. THEY HAVE 4 SAMPLES THAT WERE VERIFIED AS ERRONEOUS BY AN ALTERNATE METHOD.
Additional Manufacturer Narrative
THIS PRODUCT LOT NUMBER, B11498, IS UNDER RECALL ACTION AND IS ON FILE WITH THE FDA AS A CLASS II ACTION (REFERENCE Z-1519-2012). THE CUSTOMER HAD NOT RECEIVED THE RECALL NOTIFICATION AT THE TIME OF THE INCIDENT AND HAS SINCE RECEIVED THE NOTIFICATION AND FOLLOWED THE NECESSARY ACTIONS. PER THE CUSTOMER, NO PT TREATMENT OR ADVERSE EVENTS WERE INVOLVED WITH THIS COMPLAINT. FURTHER, (B)(4) MAKES NO CLAIM FOR PERFORMANCE OF THIS REAGENT ON A NON-IL ANALYZER WHICH THE CUSTOMER WAS USING.