INTELISWAB COVID-19 RAPID TEST
Received Jul 2, 2026 · Event occurred Jul 1, 2026
Report 3004142665-2026-00007 · MDR key 25694324
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 TEST WHICH YIELDED A NEGATIVE TEST RESULT WAS NOT PERFORMED CORRECTLY AS PER THE INSTRUCTIONS FOR USE. THE CONSUMER TOOK THE SECOND TEST, AND STATED THEY FOLLOWED 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 NEGATIVE INTEISWAB TEST RESULT, AND THEN PERFORMED ANOTHER TEST AND RECEIVED A POSITIVE RESULT. REFER TO MDR-3004142665-2026-00008 FOR THE POSITIVE RESULT.