KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 PHYSICIAN VERITOR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER IS REPORTING FALSE FLU A RESULTS."

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CUSTOMER IS REPORTING FALSE FLU A RESULTS".