HEMOSIL VON WILLEBRAND FACTOR ACTIVITY
Received May 24, 2012 · Event occurred Mar 23, 2012
Report 1217183-2012-00007 · MDR key 2593701
Device
Generic name
Factor Deficiency Test
Manufacturer
Instrumentation Laboratory Co.Model number
NACatalog number
0020004700
Lot number
B11498
Product problems
- High Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE CUSTOMER, WHO USES A STA ANALYZER, REPORTED THAT "FOR ALMOST THE PAST 3 WEEKS NOW, WE HAVE BEEN TROUBLESHOOTING THE RISTOCETIN COFACTOR ASSAY USING THE HEMOSIL VWF REAGENT LOT B11498, EXP 7/31/2012. ACCORDING TO THE CUSTOMER, THERE APPEARS TO BE A SHIFT OF SOME SORT WITH THE REAGENT. THE NORMAL RANGE FOR THE NORMAL CONTROL IS 67-91%, BUT THE CUSTOMER IS RECOVERING MUCH HIGHER RESULTS. ALSO THEY ARE RECOVERING MUCH HIGHER RESULTS FOR OTHER KNOWN ASSAY MATERIALS.
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 PATIENT TREATMENT OR ADVERSE EVENTS WERE INVOLVED WITH THIS COMPLAINT. FURTHER, IL MAKES NO CLAIM FOR PERFORMANCE OF THIS REAGENT ON A NON-IL ANALYZER WHICH THE CUSTOMER WAS USING.