INTELISWAB COVID-19 RAPID TEST
Received Jul 2, 2026 · Event occurred Jul 1, 2026
Report 3004142665-2026-00008 · MDR key 25694449
Device
Generic name
Inteliswab
Manufacturer
Orasure Technologies, Inc.Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE CONSUMER STATED THEY USED TWO TESTS. THE CONSUMER TOOK THE SECOND TEST, AND STATED THEY FOLLOWED THE INSTRUCTIONS FOR USE, AND RECEIVED A POSITIVE RESULT. THE FIRST TEST THE CONSUMER TOOK PRODUCED A NEGATIVE RESULT. HOWEVER, THE CONSUMER STATED THEY DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE CONSUMER DID NOT PROVIDE ANY PRODUCT DETAILS SUCH AS AN ITEM NUMBER OR LOT NUMBER. IT IS UNKNOWN IF THE CONSUMER HAD A PCR TEST PERFORMED TO CONFIRM EITHER RESULT. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.
Description of Event or Problem
A CONSUMER REPORTED RECEIVING A POSITIVE INTELISWAB TEST RESULT, AFTER RECEIVING A NEGATIVE INTELISWAB TEST RESULT. REFER TO MDR-3004142665-2026-00007 FOR THE NEGATIVE RESULT.