MalfunctionLGC
HERPESELECT ELISA
Received Jan 29, 2014 · Event occurred Nov 29, 2013
Report MW5034113 · MDR key 3603233
Device
Generic name
None
Product problems
- False Positive Result
Patient
63 YR
- No Information
Narrative
Description of Event or Problem
I REQUESTED AN STD PANEL FROM (B)(4), WHO USED (B)(4) TO PERFORM THE (B)(6) TEST. I UNEXPECTEDLY RECEIVED A POSITIVE RESULT FOR (B)(6), DESPITE BEING ZERO-RISK AND TOTALLY ASYMPTOMATIC. ON RESEARCHING EXTENSIVELY, I DISCOVERED THAT THIS TEST HAS A FALSE RATE OF 50% FOR RESULTS LESS THAN 3.5. (MY RESULT WAS (B)(6), WITH NORMAL BEING (B)(6).) THIS TEST SHOULD NOT BE ON THE MARKET. REASON FOR USE: TO RULE OUT (B)(6), SOMETHING THIS TEST DOES NOT DO.