INTELISWAB COVID-19 RAPID TEST

Additional Manufacturer Narrative

THE CONSUMER CALLED ORASURE TECHNOLOGIES, INC CONSUMER SUPPORT TO REPORT THEY RECEIVED 1 POSITIVE RESULT AND 3 NEGATIVE RESULTS USING INTELISWAB. THE CONSUMER ONLY HAD A LOT NUMBER FOR THE POSITIVE TEST RESULT AND DID NOT KNOW THE LOT NUMBER OF THE NEGATIVE TESTS. ADDITIONALLY, THE CONSUMER STATED THEY FOLLOWED INSTRUCTIONS BUT DID NOT OUTLINE SPECIFIC STEPS TAKEN. IT IS UNKNOWN IF A PCR TEST WAS USED TO CONFIRM THE PATIENT'S DIAGNOSIS. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY. CORRECTION TO INITIAL MDR SUBMISSION TO CORRECT MFR REPORT # AND B5 (DESCRIPTION).

Description of Event or Problem

CONSUMER TOOK 1 TEST THAT WAS POSITIVE, AND THEN 3 MORE THAT WERE NEGATIVE. THE TESTS WERE ALL PERFORMED ON THE SAME DAY AND INSTRUCTIONS FOLLOWED ON ALL TESTS.THEY WOULD LIKE REPLACEMENT TEST. OPENED TEST AND SET UP VIAL IN STAND. BLEW NOSE AND THEN SWABBED NOSE AS INSTRUCTED. PUT IN VIAL AS INSTRUCTED. AT 30 MINUTES 2 FAINT LINES APPEARED. REFER TO MDR 3004142665-2026-00002 FOR THE POSITIVE RESULT. REFER TO THE BELOW MDRS FOR THE ADDITIONAL NEGATIVE RESULTS: 3004142665-2026-00004, 3004142665-2026-00005.

Additional Manufacturer Narrative

THE CONSUMER CALLED ORASURE TECHNOLOGIES, INC CONSUMER SUPPORT TO REPORT THEY RECEIVED 1 POSITIVE RESULT AND 3 NEGATIVE RESULTS USING INTELISWAB. THE CONSUMER ONLY HAD A LOT NUMBER FOR THE POSITIVE TEST RESULT AND DID NOT KNOW THE LOT NUMBER OF THE NEGATIVE TESTS. ADDITIONALLY, THE CONSUMER STATED THEY FOLLOWED INSTRUCTIONS BUT DID NOT OUTLINE SPECIFIC STEPS TAKEN. IT IS UNKNOWN IF A PCR TEST WAS USED TO CONFIRM THE PATIENTS DIAGNOSIS. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.

Description of Event or Problem

CONSUMER TOOK 1 TEST THAT WAS POSITIVE, AND THEN 3 MORE THAT WERE NEGATIVE. THE TESTS WERE ALL PERFORMED ON THE SAME DAY AND INSTRUCTIONS FOLLOWED ON ALL TESTS.THEY WOULD LIKE REPLACEMENT TEST. OPENED TEST AND SET UP VIAL IN STAND. BLEW NOSE AND THEN SWABBED NOSE AS INSTRUCTED. PUT IN VIAL AS INSTRUCTED. AT 30 MINUTES 2 FAINT LINES APPEARED. REFER TO MDR 3004142665-2026-00002 FOR THE FALSE POSITIVE RESULT. REFER TO THE BELOW MDRS FOR THE ADDITIONAL 2 FALSE NEGATIVE RESULTS. 3004142665-2026-00004, 3004142665-2026-00005.