INSTI HIV-1/HIV-2 Antibody Test SingleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06865979010191), received between Sep 30, 2016 and Sep 30, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2016Incorrect Or Inadequate Test Results

  TESTING WITH INSTI HIV TOOK PLACE IN AN OUTREACH NEEDLE EXCHANGE SITE. THE CLIENT TESTED (B)(6) WITH INSTI AND REFUSED FOLLOW UP BLOODWORK. FROM THE CONVERSATION THE TESTER HAD WITH THE CLIENT ABOUT THE CLIENT'S (B)(6) PARTNER AND THE FACT HE SHARES NEEDLES ETC., THE TESTER WAS SUSPICIOUS ABOUT THE RESULT AND OFFERED AN ADDITIONAL TEST, WHICH THE CLIENT REFUSED. THE TESTER REVIEWED THE CLIENT'S DETAILS IN THEIR SYSTEM AND CONFIRMED THAT HE WAS A REPEAT VISITOR AND HAD BEEN SENT FOR BLOODWORK BY HIS (B)(6) CARE PROVIDER 18 MONTHS AGO. THE SITE ALSO CONFIRMED THAT THIS PATIENT INITIALLY ENTERED THE SYSTEM IN 2008 AS (B)(6) IN THE STATE OF (B)(6). THE SITE COULD NOT CONFIRM IF THE CLIENT IS ON (B)(6).

  Patient problems: HIV, Human Immunodeficiency Virus

  MAUDE report 5990836 ↗