Elecsys HIV Duo 08836973162Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336183120), received between Feb 18, 2026 and Jul 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067037 ↗
• MalfunctionJul 29, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066870 ↗
• MalfunctionMay 29, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO AND ELECSYS HBSAG II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ELECSYS HIV DUO RESULT WAS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY HIV (GEENIUS METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE INITIAL ELECSYS HBSAG II RESULT WAS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY (ROCHE E801 ECLIA METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE SAMPLE WAS REPEATED BECAUSE OF THE INITIALLY REACTIVE RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS HIV DUO ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS HBSAG II ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333754 ↗
• MalfunctionMay 29, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO AND ELECSYS HBSAG II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ELECSYS HIV DUO RESULT WAS REACTIVE. ON(B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY HIV (GEENIUS METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE INITIAL ELECSYS HBSAG II RESULT WAS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY (ROCHE E801 ECLIA METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THIS MEDWATCH WILL APPLY TO THE ELECSYS HIV DUO ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER(B)(6) FOR INFORMATION RELATED TO THE ELECSYS HBSAG II.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333752 ↗
• MalfunctionFeb 18, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 8 PATIENTS' SAMPLES TESTED WITH ELECSYS HIV DUO ASSAYS ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 AND SAMPLE 2 WERE: INITIALLY TESTED FOR HIV ON ABBOTT ALINITY, AND THE RESULTS WERE NEGATIVE. ELECSYS HIV DUO RESULTS: POSITIVE. GEENIUS HIV ½ CONFIRMATORY TEST RESULT: NEGATIVE. SAMPLE 3, SAMPLE 4, SAMPLE 5, SAMPLE 6, SAMPLE 7, AND SAMPLE 8 WERE: ELECSYS HIV DUO RESULTS: POSITIVE. GEENIUS HIV ½ CONFIRMATORY TEST RESULTS: NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379356 ↗