INSTI HIV-1/HIV-2 Antibody Test 90-1019Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00686597010198), received between May 17, 2021 and Dec 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023False Negative Result; False Negative Result

  COASTAL BEND WELLNESS FOUNDATION IN TEXAS, USA REPORTED 2 X FALSE NEGATIVE (FN) RESULTS USING THE INSTI HIV-1/HIV-2 ANTIBODY TEST FROM KIT LOT 1019230157 ON (B)(6) 2023, FROM TWO INDIVIDUAL PATIENTS WITH FINGERSTICK BLOOD SAMPLES. BOTH PATIENTS TESTED POSITIVE FOR HIV AT THE PLASMA DONATION AND WERE REPORTED TO THE LOCAL HEALTH DEPARTMENT. INFORMATION AVAILABLE FOR BOTH PATIENTS: ON (B)(6), 2023, PATIENT#1 TESTED NEGATIVE FOR HIV USING INSTI, HOWEVER HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. ON (B)(6), 2023, PATIENT#2 TESTED NEGATIVE FOR HIV USING INSTI, HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. THE CUSTOMER HAS TESTED THE INSTI CONTROLS TO MAKE SURE THE TEST KITS WORKING, THE TEST RESULTS WERE AS EXPECTED, AND IT WAS CONFIRMED THAT THE KITS ARE STORED AS PER THE IFU. THE CUSTOMER PROVIDED NO PICTURES OF THE FALSE NEGATIVE RESULTS WITH INSTI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376404 ↗
• MalfunctionDec 21, 2023False Negative Result; False Negative Result

  AN INITIAL REPORT WAS SUBMITTED TO THE FDA ON 18 OCTOBER 2023 (MDR#3003871407-2023-00002), REGARDING ONE FALSE NEGATIVE RESULT WITH INSTI HIV-1/HIV-2 ANTIBODY TEST LOT NO 1019230073. A PATIENT REPORTED A FALSE NEGATIVE RESULT WITH AN INSTI HIV-1/HIV-2 ANTIBODY TEST (LOT NO. 1019230073) DURING A ROUTINE STI SCREENING ON (B)(6) 2023, WHEN THEY VISITED A CLINIC FOR PREP. THE PATIENT'S BLOOD WAS LATER TESTED USING WESTERN BLOT, WHICH SHOWED A POSITIVE HIV RESULT ON (B)(6) 2023. BIOLYTICAL RECEIVED THE COMPLAINT OF THE FALSE NEGATIVE ON (B)(6) 2023. A SECOND INSTI HIV TEST WAS NOT CONDUCTED DUE TO INSUFFICIENT PATIENT SAMPLE. BIOLYTICAL WOULD LIKE TO SUBMIT THIS FOLLOW-UP REPORT WITH THE TESTING RESULTS OF THE RETURNED KITS THAT WERE INVESTIGATED INTERNALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373436 ↗
• MalfunctionMay 17, 2021False Negative Result; False Negative Result

  CUSTOMER REPORTED A (B)(6) RESULTS WITH INSTI (B)(6) ANTIBODY TEST. PATIENT WAS KNOWN (B)(6) . INITIALLY IT WAS UNDERSTOOD THAT THE PATIENT WAS ON ART MEDICATION. HOWEVER, AFTER A SECOND CALL WITH THE CLINIC, IT IS UNKNOWN IF THE PATIENT IS TAKING ART MEDICATION.

  Patient problems: Insufficient Information

  MAUDE report 11838659 ↗
• MalfunctionMay 17, 2021False Negative Result; False Negative Result

  CUSTOMER REPORTED A FALSE NEGATIVE RESULTS WITH INSTI HIV-1/HIV-2 ANTIBODY TEST. PATIENT WAS KNOWN (B)(6). INITIALLY IT WAS UNDERSTOOD THAT THE PATIENT WAS ON ART MEDICATION. HOWEVER, AFTER A SECOND CALL WITH THE CLINIC, IT IS UNKNOWN IF THE PATIENT IS TAKING ART MEDICATION.

  Patient problems: Insufficient Information

  MAUDE report 11838576 ↗