WALGREENS COVID-19 & FLU A + B ANTIGEN TEST

Description of Event or Problem

THE COMPLAINT INVOLVES A CUSTOMER REPORT OF AN INVALID TEST RESULT, INDICATED BY THE ABSENCE OF CONTROL LINES IN BOTH RESULT WINDOWS. THE COMPLAINANT STATED THAT A PORTION OF THE SPECIMEN OVERFLOWED THE SAMPLE WELL DUE TO RAPID ADDITION OF THE SAMPLE. INSTEAD OF PERFORMING REPEAT TESTING WITH A NEW SPECIMEN AND TEST KIT, AS RECOMMENDED IN THE QUICK REFERENCE INSTRUCTIONS (QRI) FOR ANY INVALID RESULT, THE COMPLAINANT ADDED AN ADDITIONAL 8 DROPS OF SAMPLE TO THE SAME USED TEST CASSETTE, WHICH AGAIN PRODUCED AN INVALID RESULT, AS EXPECTED. THE FOLLOWING DAY, THE PATIENT REPORTEDLY TESTED POSITIVE AT A DOCTOR'S OFFICE; HOWEVER, NO INFORMATION WAS PROVIDED REGARDING THE TESTING METHODOLOGY USED AT THAT FACILITY. THERE WERE NO REPORTS OR ALLEGATIONS OF ANY ADVERSE EVENT ASSOCIATED WITH THE INVALID TEST RESULT. THE LOT NUMBER REPORTED TO THE MANUFACTURER WAS 2503179 DEN.

Additional Manufacturer Narrative

THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. THE INVESTIGATION USED RETAINED SAMPLES OF THE LOT IN USE AT THE TIME OF THE EVENT. WHEN TESTED NO IRREGULARITIES WERE OBSERVED. ALL DEVICES PERFORMED AS EXPECTED WHEN TESTED PER THE STANDARD PROCEDURE. NO PRODUCT PROBLEM IDENTIFIED, THE CAUSE OF THIS EVENT IS UNKNOWN.