Elecsys HIV Duo 08836973190Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 07613336166949), received between Aug 30, 2021 and Sep 29, 2026 — classified as 105 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (79 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 25 most recent of 105 reports, 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 ↗
• 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 ↗
• MalfunctionApr 16, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HIV DUO RESULT FOR ONE SERUM SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6)-2026: THE INITIAL RESULT OF THE PATIENT'S SERUM SAMPLE FROM THE ANALYZER WAS 32.0 COI (REACTIVE). ON (B)(6) 2026: THE INITIAL RESULT OF THE PATIENT'S PLASMA SAMPLE FROM THE ADVIA CENTAUR ANALYZER WAS <0.05 INDEX (NON-REACTIVE). THE REPEAT RESULT FROM THE ADVIA CENTAUR ANALYZER WAS 0.204 INDEX (NON-REACTIVE). THE REPEAT RESULT OF THE PATIENT'S PLASMA SAMPLE FROM THE ANALYZER WAS 0.232 COI (NON-REACTIVE). THE REPEAT RESULT OF THE PATIENT'S SERUM SAMPLE FROM AN ALINITY ANALYZER WAS "NEGATIVE". .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902506 ↗
• MalfunctionApr 16, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS HIV DUO ASSAY ON A COBAS E 801 ANALYTICAL UNIT. ELECSYS HIV DUO (AHIV SUB-RESULTS) ALL RESULTS IN COI SAMPLE 1: INITIAL RESULT: 3.89 COI. 1ST REPEAT RESULT: 1.70 COI. ON (B)(6) 2026: 2ND REPEAT RESULT: 9.18 COI. 3RD REPEAT RESULT: 9.20 COI (LOT: 888322) ALL THE RESULTS WERE OBTAINED USING THE LOT NUMBER 910947, EXCEPT FOR THE 3RD REPEAT RESULT, WHICH WAS OBTAINED USING THE LOT NUMBER 888322. SAMPLE 2: INITIAL RESULT: 37.8 COI. 1ST REPEAT RESULT: 19.6 COI. ON (B)(6) 2026: 2ND REPEAT RESULT: 180 COI. 3RD REPEAT RESULT: 183 COI. ALL THE RESULTS WERE OBTAINED USING THE LOT NUMBER 910947. SAMPLE 1 AND SAMPLE 2 WERE THEN REPEATED USING THE TUBES THAT WERE SENT TO THE CHEMISTRY AREA, AND THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULTS WERE CONSISTENT WITH THE PATIENTS' CLINICAL PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893537 ↗
• MalfunctionApr 11, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULTS WERE 40.9 COI AND 40.4 COI (REACTIVE). ON (B)(6) 2026 AND (B)(6) 2026, THE SAMPLE WAS TESTED AT ANOTHER LABORATORY FOR CONFIRMATION USING AN ALINITY ANALYZER, AND THE RESULTS WERE 0.16 COI, 0.15 COI, 0.14 COI, AND 0.13 COI (NON-REACTIVE). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846650 ↗
• MalfunctionApr 10, 2026False Positive Result; Improper or Incorrect Procedure or Method

  THERE WAS AN ALLEGATION OF QUESTIONABLE POSITIVE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS HIV DUO (HIV DUO) ON A COBAS E801 ANALYZER. PATIENT 1 RESULT FROM THE E801 ANALYZER WAS 1.67 COI (POSITIVE). THE SUB RESULTS OF THE ASSAY WERE HIVAG 0.196 COI AND AHIV 1.67 COI. THE HIV RESULT FROM THE MINDRAY METHOD WAS 0.52 S/CO (NEGATIVE). ON (B)(6) 2026, PATIENT 2 RESULT FROM THE E801 ANALYZER WAS 16.4 COI (POSITIVE). THE SUB RESULTS OF THE ASSAY WERE HIVAG 0.184 COI AND AHIV 16.4 COI. THE SAMPLE WAS REPEATED BY THE ABBOTT METHOD WITH AN HIV RESULT OF 0.08 S/CO (NEGATIVE). NO REPEAT TESTING ON THE E801 ANALYZER AND NO CONFIRMATORY TESTING (PCR OR WESTERN BLOT) WAS PERFORMED FOR EITHER PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840238 ↗
• MalfunctionApr 3, 2026False Positive Result; Insufficient Device Problem Information

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HIV DUO (HIV DUO) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 47.7 COI (POSITIVE). THE REPEAT RESULT WAS 45.9 COI (POSITIVE). THE HIV RESULTS FROM THE ABBOTT METHOD WERE 0.07 S/CO (NEGATIVE) AND 0.09 S/CO (NEGATIVE). THE HIV POLYMERASE CHAIN REACTION (PCR) RESULT WAS NEGATIVE. THE NEGATIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778880 ↗
• MalfunctionApr 1, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 CORE UNIT. THE CUSTOMER QUESTIONED THE RESULTS AS THE ANTIGEN RESULTS WERE REACTIVE BUT THE ANTIBODY RESULTS WERE NEGATIVE. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL RESULT OF 1.98 COI, INTERPRETED AS REACTIVE. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON ANOTHER E801 ANALYZER AND THE RESULT WAS 3.80 COI, INTERPRETED AS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS TESTED ON AN E601 ANALYZER USING AM HIV COMBI PT REAGENT AND THE RESULT WAS 0.463 COI, INTERPRETED AS NON-REACTIVE. THE SAMPLE ALSO UNDERWENT NUCLEIC ACID TESTING AND WAS TESTED ON A MINDRAY ANALYZER AND THE RESULTS WERE NEGATIVE. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL RESULT OF 1.18 COI, INTERPRETED AS REACTIVE. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON ANOTHER E801 ANALYZER AND THE RESULT WAS 1.15 COI, INTERPRETED AS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS TESTED ON AN E601 ANALYZER USING AM HIV COMBI PT REAGENT AND THE RESULT WAS 0.306 COI, INTERPRETED AS NON-REACTIVE. THE SAMPLE ALSO UNDERWENT NUCLEIC ACID TESTING AND WAS TESTED ON A MINDRAY ANALYZER AND THE RESULTS WERE NEGATIVE. ON (B)(6) 2026,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753291 ↗
• MalfunctionMar 30, 2026False Positive Result

  THE INITIAL REPORTER QUESTIONED A POSITIVE RESULT FOR 1 PATIENT TESTED FOR ELECSYS HIV DUO (HIV DUO) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS "POSITIVE." THE SPECIFIC RESULT WAS NOT PROVIDED. A REPEAT SAMPLE ON (B)(6) 2026 WAS "NEGATIVE." THE SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717979 ↗
• MalfunctionMar 26, 2026False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HIV DUO RESULTS FOR 19 PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE RESULTS FROM THE ANALYZER WERE POSITIVE. THE RESULTS FROM THE CENTER FOR DISEASE CONTROL (CDC) WERE NEGATIVE. THE CUSTOMER IS QUESTIONING THE RESULTS FROM THE ASSAY'S NEW VERSION COMPARED TO THE PREVIOUS ONE. THE DATE OF EVENT STATED IN THIS MEDWATCH WAS THE DATE WHEN THE CLIENT STARTED USING THE REAGENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696984 ↗
• MalfunctionMar 24, 2026False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS HIV COMBI PT (HIV COMBI) AND ELECSYS HIV DUO (HIV DUO) ON A COBAS E 602 MODULE AND A COBAS E 601 MODULE. THIS MEDWATCH WILL COVER HIV DUO. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HIV COMBI RESULTS. THE INITIAL HIV COMBI RESULT WAS 120 COI (POSITIVE). THE REPEAT RESULT WAS 104 COI (POSITIVE). ON (B)(6) 2026, A NEW SAMPLE WAS OBTAINED, AND THE HIV COMBI RESULT WAS 140 COI (POSITIVE). THE CUSTOMER PERFORMED ADDITIONAL HIV TESTING USING AUTOBIO POINT OF CARE TESTING (POCT) CHEMILUMINESCENCE IMMUNOASSAY (CLIA) WITH A RESULT OF 0.059 COI (NEGATIVE) AND DAAN NUCLEIC ACID TESTING (NAT) WITH A RESULT OF < 125 COPIES/ML (NEGATIVE). ONE OF THE SAMPLES WAS RECENTRIFUGED AND REPEATED. IT IS NOT CLEAR IF THIS WAS THE ORIGINAL SAMPLE OR THE 2ND SAMPLE. THE HIV COMBI RESULTS WERE 117 COI (POSITIVE) AND 103 COI (POSITIVE). THE HIV DUO RESULT WAS 120 COI (POSITIVE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681633 ↗
• MalfunctionMar 19, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 1.12 COI (REACTIVE). ON (B)(6) 2026, REPEAT TESTING WAS PERFORMED ON THE SAME SAMPLE TUBE, AND THE RESULT WAS 0.239 COI (NON-REACTIVE). TWO ADDITIONAL SAMPLE TUBES DRAWN FROM THE PATIENT AT THE SAME TIME WERE TESTED, AND THE RESULTS WERE 0.242 COI (NON-REACTIVE) AND 0.289 COI (NON-REACTIVE). PATIENT 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 4.42 COI (REACTIVE). ON (B)(6) 2026, REPEAT TESTING WAS PERFORMED ON THE SAME SAMPLE TUBE, AND THE RESULT WAS 4.50 COI (REACTIVE). ANOTHER TUBE TAKEN FROM THIS PATIENT WAS TESTED, AND THE RESULT WAS 0.227 COI (NON-REACTIVE). PATIENT 3: ON (B)(6) 2026, THE INITIAL RESULT WAS REACTIVE. THE REPEAT RESULT FROM THE SAME SAMPLE TUBE WAS NON-REACTIVE. A NEW SAMPLE WAS REQUESTED FROM THE PATIENT, WHICH ALSO YIELDED A NON-REACTIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638972 ↗
• MalfunctionMar 12, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS HIV DUO ON TWO COBAS E 801 ANALYTICAL UNITS. THE FIRST SAMPLE RESULTED IN AN HIV DUO VALUE OF 124 COI (REACTIVE), WITH SUB-RESULTS OF HIV AG = 124 COI AND ANTI-HIV = 0.152 COI WHEN TESTED ON THE FIRST E 801 ANALYZER. THIS SAMPLE WAS REPEATED ON THE FIRST E 801 ANALYZER, RESULTING IN A VALUE OF 124 COI (REACTIVE), WITH SUB-RESULTS OF HIV AG = 124 COI AND ANTI-HIV = 0.257 COI. ANOTHER TUBE OF THE FIRST SAMPLE WAS TESTED IN A SISTER LABORATORY ON A SECOND E 801 ANALYZER, RESULTING IN AN HIV DUO VALUE OF 97.3 COI (REACTIVE), WITH SUB-RESULTS OF HIV AG = 97.3 COI AND ANTI-HIV = 0.158 COI. A THIRD TUBE OF THE FIRST SAMPLE WAS TESTED ON THE SECOND E 801 ANALYZER, RESULTING IN AN HIV DUO VALUE OF 88.8 COI (REACTIVE), WITH SUB-RESULTS OF HIV AG = 88.1 COI AND ANTI-HIV = 0.162 COI. THE FIRST SAMPLE WAS TESTED ON AN ABBOTT ANALYZER, RESULTING IN AN HIV VALUE OF 0.23 S/CO (NON-REACTIVE). THE THIRD TUBE OF THE SAMPLE WAS ALSO TESTED ON THE ABBOTT ANALYZER, RESULTING IN AN HIV VALUE OF 0.24 S/CO (NON-REACTIVE). THE PCR RESULT FOR THE FIRST SAMPLE WAS NEGATIVE. A SECOND SAMPLE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584252 ↗
• MalfunctionMar 12, 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: THE INITIAL RESULT WAS 1.36 COI. ON (B)(6) 2026, THE SAMPLE WAS REPEATED IN A DIFFERENT LABORATORY USING 2 DIFFERENT METHODS (ABBOTT ALINITY HIV COMBO AND BIORAD GENSCREEN ULTRA HIV AG/AB), AND THE REPEAT RESULTS WERE BOTH NEGATIVE. PATIENT 2: ON (B)(6) 2026: THE INITIAL RESULT WAS 2.71 COI. ON (B)(6) 2026: THE REPEAT RESULT WAS 2.48 COI. THE SAMPLE WAS ALSO REPEATED IN A DIFFERENT LABORATORY USING 2 DIFFERENT METHODS (ABBOTT ALINITY HIV COMBO AND BIORAD GENSCREEN ULTRA HIV AG/AB), AND THE REPEAT RESULTS WERE BOTH NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579502 ↗
• MalfunctionMar 10, 2026False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS HIV DUO (HIV DUO) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE E402 ANALYZER WAS 1.77 COI (POSITIVE). THE REPEAT RESULT WAS 2.00 COI (POSITIVE). ON (B)(6) 2026, THE HIV RESULT FROM THE ABBOTT METHOD WAS 0.056 S/CO (NEGATIVE). ON AN UNKNOWN DATE, THE RESULT FROM A RAPID TEST WAS NEGATIVE. NO CONFIRMATORY TESTING WAS PERFORMED. THE NEGATIVE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558839 ↗
• MalfunctionMar 9, 2026False Positive Result

  THERE WAS AN ALLEGATION OF FALSE-POSITIVE ELECSYS HIV DUO RESULTS FOR 2 PATIENTS ON A COBAS E 801 ANALYTICAL UNIT. IT WAS ALLEGED THAT BOTH PATIENTS HAD PERSISTENT REACTIVE ELECSYS HIV DUO RESULTS OVER SEVERAL YEARS. PATIENT 1: THE PATIENT'S HIV DUO RESULT WAS 44.3 COI ON (B)(6) 2023, 15.9 COI ON (B)(6) 2025, AND 19.7 COI ON (B)(6) 2026. PATIENT 2: THE PATIENT'S HIV DUO RESULT WAS 46.5 COI ON (B)(6) 2024, 44.5 COI ON (B)(6) 2024, AND 25.9 COI ON (B)(6) 2025. BOTH PATIENTS CONSISTENTLY SHOWED REACTIVE RESULTS FOR ANTIGEN (HIV AG), BUT NON-REACTIVE FOR ANTIBODY (ANTI-HIV). REPEAT TESTING ON THE COBAS E801 CONFIRMED THESE RESULTS (NUMERICAL REPEAT RESULTS WERE NOT PROVIDED). PATIENT 1: THE PATIENT'S HIV AG RESULT WAS 44.3 COI ON (B)(6) 2023, 15.9 COI ON (B)(6) 2025, AND 19.7 COI ON (B)(6) 2026. PATIENT 1: THE PATIENT'S ANTI-HIV RESULT WAS 0.085 COI ON (B)(6) 2023, 0.101 COI ON (B)(6) 2025, AND 0.099 COI ON (B)(6) 2026. PATIENT 2: THE PATIENT'S HIV AG RESULT WAS 46.5 COI ON (B)(6) 2024, 44.5 COI ON (B)(6) 2024, AND 25.9 COI ON (B)(6) 2025. PATIENT 2: THE PATIENT'S ANTI-HIV RESULT WAS 0.091 COI ON (B)(6) 2024, 0.083 COI ON (B)(6) 2024, AND 0.082 COI ON (B)(6) 2025. BOTH PATIENTS WERE TE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550946 ↗