Elecsys HIV Duo 08836973160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336215845), received between Aug 28, 2025 and Dec 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive 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 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HIV DUO AND ELECSYS ANTI-HCV II ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE HIV DUO ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-HCV ASSAY. THE SAMPLE RESULTED IN AN HIV DUO VALUE OF 3.03 COI (REACTIVE). THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING A QUALITATIVE NUCLEIC ACID PCR TEST AND THE HIV RESULT WAS "NOT DETECTED". THE PCR TEST RESULT WAS DEEMED CORRECT. THE SAMPLE RESULTED IN AN ANTI-HCV VALUE OF 0.0439 COI (NON-REACTIVE). THE SAMPLE WAS REPEATEDLY NON-REACTIVE FOR ANTI-HCV. THE PATIENT WAS TESTED AT A PLASMA DONATION CENTER AND THE PATIENT TESTED POSITIVE FOR "HEPATITIS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829761 ↗
• MalfunctionNov 19, 2025False Positive Result; Contamination /Decontamination Problem; False Positive Result; Contamination /Decontamination Problem

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE POSITIVE ELECSYS HIV DUO RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS REACTIVE, AND ALSO REACTIVE TWICE WITH THE EFLOW. THE SAMPLE WAS SENT OUT FOR CONFIRMATION TESTING, AND THE RESULT WAS NEGATIVE FOR ANTIBODIES. THE CUSTOMER SENT THE SAMPLE OUT FOR RIBONUCLEIC ACID (RNA) TESTING, AND IT WAS DETERMINED TO BE NON-REACTIVE. ALL OF THE RESULTS WERE REPORTED IN REAL-TIME; HOWEVER, THEY WAITED FOR ALL OF THE RESULTS TO BE COMPLETED BEFORE ACTING ON THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594741 ↗
• MalfunctionSep 17, 2025False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FOR 2 PATIENT SERUM SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, SAMPLE 1 HAD INITIAL HIV RESULTS OF 2.160 COI, 2.150 COI, AND 2.170 COI, ALL INTERPRETED AS REACTIVE. ON (B)(6) 2025, SAMPLE 2 HAD INITIAL HIV RESULTS OF 34.80 COI, 36.0 COI, AND 35.0 COI, ALL INTERPRETED AS REACTIVE. THE PATIENTS' DOCTOR QUESTIONED THE RESULTS AS THEY WERE BOTH TAKING PRE-EXPOSURE PROPHYLAXIS HIV MEDICATION. BOTH SAMPLES WERE SENT OUT FOR PCR CONFIRMATORY TESTING PER INTERNAL PROTOCOL AND BOTH SAMPLE RESULTS WERE DETERMINED TO BE NOT DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073464 ↗
• MalfunctionAug 28, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 11 PATIENT SAMPLES TESTED WITH ELECSYS HIV DUO. THE SAMPLES WERE TESTED ON ONE OF THREE COBAS E 801 ANALYTICAL UNIT ANALYZERS, E801 #1, E801 #2, AND E801 #3. E801 #3 IS LOCATED AT A SECOND SITE. PLEASE REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE RESULTS MEASURED WITH THE ELECSYS HIV DUO ASSAY DID NOT MATCH RESULTS OBTAINED WITH THE ABBOTT ARCHITECT I2000 METHOD AND THE BIO-RAD GEENIUS METHOD. A DOCTOR AT THE FACILITY INDICATED THEY ARE TRYING TO SWITCH FROM THE ABBOTT METHOD TO THE ROCHE METHOD, BUT THE CORRELATIONS KEEP FAILING. SAMPLES RECOVERING VALUES NEAR THE CUTOFF ARE SHOWING UP REACTIVE WITH THE ROCHE METHOD AND NEGATIVE WITH THE ABBOTT METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915926 ↗