KIT FLU A+B 30 TEST HOSPITAL VERITOR

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER REPORTING FALSE POSITIVES WITH VER 256041 TEST KIT LOT 0051984."

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER REPORTING FALSE POSITIVES WITH VER 256041 TEST KIT LO 0051984"

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041), BATCH NUMBER 0051984 . BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE RESULT COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. RETURNED PRODUCT TESTING WAS COMPLETED AND ALL DEVICES TESTED HAD NORMAL INTENDED RESULTS. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.