Elecsys HIV DuoRecalls & reported problems across all models

We found 3 models of Elecsys HIV Duo by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2021 and Sep 29, 2026 — classified as 114 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (88 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys HIV Duo problems

Elecsys HIV Duo models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys HIV Duo 08836973190

  Test, HIV detection
  105 reports
• Elecsys HIV Duo 08836973162

  Serology tests used for infectious disease screening of blood and plasma donations
  5 reports
• Elecsys HIV Duo 08836973160

  Test, HIV detection
  4 reports

Recent Elecsys HIV Duo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932045 ↗
• MalfunctionSep 28, 2026False Positive Result

  There was an allegation of questionable Elecsys HIV Duo results for 1 patient sample on a cobas e 801 analytical unit.The initial result was 73.3 COI (positive).A western blot test and an HIV viral load test were performed on the patient sample and the results were negative.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917899 ↗
• MalfunctionAug 26, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457371 ↗
• MalfunctionAug 6, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161888 ↗
• 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 ↗
• MalfunctionMay 22, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ALINITY ANALYZER. THE INITIAL RESULT WAS 4.21 COI (REACTIVE). A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND THE RESULT WAS 3.87 COI (REACTIVE). THE FIRST SAMPLE WAS REPEATED AND THE RESULT WAS 4.47 COI (REACTIVE). A PATIENT SAMPLE WAS TESTED ON AN ABBOTT ALINITY ANALYZER AND THE RESULT WAS NEGATIVE. A PCR TEST WAS ALSO PERFORMED AND THE RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257322 ↗
• MalfunctionMay 13, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. IT WAS ALLEGED THAT THE PATIENT HAD POSITIVE ELECSYS HIV DUO RESULTS. HOWEVER, THE RESULTS DON'T MATCH THE PATIENT'S CLINICAL DIAGNOSIS. IT WAS ALLEGED THAT THE PATIENT HAD A FALSE-POSITIVE RESULT IN (B)(6) 2026 AND ANOTHER FALSE-POSITIVE RESULT ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163644 ↗
• MalfunctionMay 12, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE POSITIVE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HIV DUO ON A COBAS PURE E 402 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HIV DUO VALUE OF 15.5 COI (REACTIVE). THE SAMPLE WAS REPEATED, RESULTING IN AN HIV DUO VALUE OF 14.2 COI (REACTIVE). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2026, RESULTING IN AN HIV DUO VALUE OF 14.7 COI (REACTIVE), WITH AN ANTI-HIV SUB-RESULT OF 14.7 COI (REACTIVE) AND AN HIV AG SUB-RESULT OF 0.204 COI (NON-REACTIVE). THE SAMPLE WAS SENT TO OTHER LABORATORIES USING UNKNOWN METHODS AND THE HIV RESULTS WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152496 ↗
• MalfunctionMay 11, 2026False Positive Result; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HIV DUO RESULT FOR ONE PATIENT'S SAMPLE TESTED ON THE COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS A DATA FLAG WITH NO NUMERICAL RESULT. THE FIRST REPEAT RESULT WAS 1.29 COI (REACTIVE). THE SECOND REPEAT RESULT WAS 0.242 COI OR 0.29 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134910 ↗
• MalfunctionMay 5, 2026False Positive Result

  THERE WAS AN ALLEGATION OF FALSE-POSITIVE ELECSYS HIV DUO RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ELECSYS HIV DUO RESULT WAS 100 COI (REACTIVE); THE ANTI-HIV RESULT WAS 0.0855 COI (NON-REACTIVE), AND THE HIV AG RESULT WAS 100 COI (REACTIVE). ON (B)(6) 2026, THE REPEATED ELECSYS HIV DUO RESULT WAS 89.7 COI (REACTIVE); THE ANTI-HIV RESULT WAS 0.0850 COI (NON-REACTIVE), AND THE HIV AG RESULT WAS 89.7 COI (REACTIVE). ON (B)(6) 2026, THE REPEATED ELECSYS HIV DUO RESULT WAS 89.8 COI (REACTIVE); THE ANTI-HIV RESULT WAS 0.0778 COI (NON-REACTIVE), AND THE HIV AG RESULT WAS 89.8 COI (REACTIVE). IT WAS REPORTED THAT A RAPID HIV TEST WAS PERFORMED ON THIS PATIENT, YIELDING A NEGATIVE RESULT. A VIRAL LOAD HIV TEST WAS ALSO CONDUCTED, AND THE RESULT WAS UNDETECTABLE. THE TESTING METHODS WERE NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT'S MEDICAL HISTORY FOR (B)(6) 2025 SHOWED A REACTIVE ELECSYS HIV DUO RESULT THAT ENTERED THE DIAGNOSTIC ALGORITHM WITH THE SAME FINDINGS: AN UNDETECTABLE VIRAL LOAD AND A NEGATIVE RAPID TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082968 ↗
• MalfunctionApr 23, 2026False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS HIV DUO ASSAY ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: INITIAL RESULT: 442 COI. 1ST REPEAT RESULT: 448 COI. 2ND REPEAT RESULT: 442 COI. WESTERN BLOT TEST RESULT: NEGATIVE. 3RD REPEAT RESULT: NEGATIVE WHEN TESTED ON AN ABBOTT ANALYZER. ON (B)(6) 2026, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED ON A COBAS E 801 AT A DIFFERENT HOSPITAL, AND THE RESULTS WERE 312 COI, 319 COI, AND 310 COI. PATIENT 2 WAS TESTED ON (B)(6)2026: INITIAL RESULT: 97.30 COI. 1ST REPEAT RESULT: 97.0 COI. 2ND REPEAT RESULT: 94.90 COI. WESTERN BLOT TEST RESULT: NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971200 ↗
• MalfunctionApr 22, 2026False Positive Result

  WE RECEIVED AN ALLEGATION OF FALSELY REACTIVE ELECSYS HIV DUO RESULTS FOR SEVERAL PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER STATED THAT THEY HAVE IDENTIFIED SEVERAL WEAKLY REACTIVE ELECSYS HIV DUO RESULTS (1.01-8.6 COI), PREDOMINANTLY IN PREGNANT WOMEN, WHICH WERE NON-REACTIVE WHEN VERIFIED WITH AN ALTERNATIVE IMMUNOCHROMATOGRAPHIC METHOD. THE CUSTOMER PROVIDED TWO PATIENT SAMPLES WITH ALLEGEDLY FALSE REACTIVE RESULTS. THE PATIENT SAMPLES WERE FURTHER TESTED USING WESTERN BLOT (RECOMMENDED CONFIRMATORY TEST FOR THE ELECSYS HIV DUO). PATIENT SAMPLE 1: IN THE PATIENT'S FIRST TRIMESTER OF PREGNANCY, THE RESULT WAS 3.28 COI (REACTIVE). IN THE PATIENT'S SECOND TRIMESTER, THE RESULT WAS 2.85 COI (REACTIVE). THE RESULT OF THE WESTERN BLOT CONFIRMATORY TEST WAS "NON-REACTIVE". PATIENT SAMPLE 2: IN THE PATIENT'S FIRST TRIMESTER OF PREGNANCY, THE RESULT WAS 3.18 COI (REACTIVE). IN THE PATIENT'S SECOND TRIMESTER, THE RESULT WAS 3.94 COI (REACTIVE). THE PATIENT HAD A PREGNANCY LOSS, AND THE RESULT OF THE PATIENT'S 2026 FIRST QUARTERLY CHECK-IN WAS 2.83 COI (REACTIVE). THE RESULT OF THE WESTERN BLOT CONFIRMATORY TEST WAS "NON-REACTIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956656 ↗

Other Roche Diagnostics GmbH products

• cobas e 411 Immunoassay Analyzer2 models · 1,218 reports
• cobas e 801 Immunoassay analyzer3 models · 713 reports · 1 recall
• CoaguChek XS PT strips2 models · 632 reports
• CoaguChek XS Patient Self Testing Care Kit2 models · 346 reports
• Elecsys FT3 III4 models · 283 reports
• Elecsys Estradiol III2 models · 162 reports
• Elecsys TSH4 models · 155 reports
• Sodium electrode3 models · 150 reports