Elecsys Anti-HCV IIRecalls & reported problems across all models

We found 5 models of Elecsys Anti-HCV II by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2018 and Sep 30, 2026 — classified as 113 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (74 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 Anti-HCV II problems

Elecsys Anti-HCV II models

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

• Elecsys Anti-HCV II 08837058190

  Assay, enzyme linked immunosorbent, hepatitis c virus
  44 reports
• Elecsys Anti-HCV II 08836981190

  Assay, enzyme linked immunosorbent, hepatitis c virus
  31 reports
• Elecsys Anti-HCV II 07026889190

  ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
  26 reports
• Elecsys Anti-HCV II 08837031190

  Assay, enzyme linked immunosorbent, hepatitis c virus
  9 reports
• Elecsys Anti-HCV II 06368921160

  Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus
  3 reports

Recent Elecsys Anti-HCV II adverse event reports

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

• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949325 ↗
• MalfunctionSep 28, 2026False Positive Result

  The initial reporter stated they received discrepant results for one patient sample tested with Elecsys Anti-HCV II on two cobas e 801 analytical units. The sample was tested twice on the customer's e 801 analyzer, resulting in Anti-HCV values of 26.4 COI (reactive) and 26.5 COI (reactive). The sample was provided for investigation, where it was tested twice on a second e 801 analyzer on 10-Sep-2026, resulting in Anti-HCV values of 26.0 COI (reactive) and 26.1 COI (reactive). During investigations, the sample was tested with an unknown CLIA assay method, resulting in an Anti-HCV value of 0.67 (negative). No units of measure were provided. During investigations, the sample was also tested with the Fujirebio HCV score method, resulting in the following values:C1 antigen = negative.C2 antigen = negative.E2 antigen = negative.NS3 antigen = "+/-".NS4 antigen = negative.NS5 antigen = negative.final result = inconclusive.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913429 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  We received an allegation about discrepant results for 2 patients' samples tested with Elecsys Anti-HCV II assay on a cobas e 801 analytical unit.Patient 1:Initial result: 1.62 COI (Reactive).1st Repeat result: 1.65 COI (Reactive).2nd Repeat result: 1.65 COI (Reactive).On (b)(6)2026, the sample was repeated at a different customer's branch:3rd Repeat result: Non-Reactive (tested using the ElectroChemiluminescence Immunoassay (ECLIA) method). The result was confirmed by an Enzyme-Linked Fluorescent Assay (ELFA) method.Patient 2 was tested on (b)(6)2026:Initial result: 2.75 COI (Reactive).1st Repeat result: 2.80 COI (Reactive).2nd Repeat result: 2.78 COI (Reactive).On (b)(6)2026:The result from another laboratory, which uses the Chemiluminescence Immunoassay (CLIA) method, was 0.11 S/CO (Negative).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898152 ↗
• MalfunctionSep 11, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737228 ↗
• MalfunctionJul 29, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069966 ↗
• MalfunctionJun 12, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ANALYZER. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL RESULT OF 24.7 COI (REACTIVE). ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON ANOTHER E 801 ANALYZER AND THE RESULT WAS 25.0 COI (REACTIVE). THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ANALYZER AND THE RESULT WAS 0.48 COI (NON-REACTIVE). THE SAMPLE WAS ALSO SENT FOR CONFIRMATORY MOLECULAR TESTING AND THE RESULT WAS NON-REACTIVE. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL RESULT OF 22.9 COI (REACTIVE). ON (B)(6) 2026, THE SAMPLE WAS REPEATED AND THE RESULT WAS 25.4 COI (REACTIVE). THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ANALYZER AND THE RESULT WAS 0.91 COI (NON-REACTIVE). THE SAMPLE WAS ALSO SENT FOR CONFIRMATORY MOLECULAR TESTING AND THE RESULT WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488127 ↗
• MalfunctionJun 12, 2026False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS ANTI-HCV II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL AND REPEAT RESULTS FOR PATIENT 1 AND PATIENT 2 WERE BOTH REACTIVE. THE RIBONUCLEIC ACID (RNA) TEST RESULTS FOR BOTH PATIENT 1 AND PATIENT 2 WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487896 ↗
• MalfunctionMay 15, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED FALSE POSITIVE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT TESTED WITH ELECSYS ANTI-HCV II ON A COBAS E 801 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS DID NOT AGREE WITH THE PATIENT'S CLINICAL DIAGNOSIS. THE FIRST SAMPLE INITIALLY RESULTED IN AN ANTI-HCV VALUE OF 145 COI (REACTIVE). THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 144 COI (REACTIVE). THE SAMPLE WAS TESTED USING THE AUTOBIO ANTU METHOD, RESULTING IN AN ANTI-HCV VALUE OF 0.107 (NEGATIVE). THE SAMPLE WAS ALSO REPEATED USING THE MAGLUMI SNIBE ANTI-HCV METHOD, RESULTING IN A VALUE OF 0.56 (NEGATIVE). THE SAMPLE WAS TESTED FOR HCV AG AND IT WAS NEGATIVE. THE SAMPLE WAS ALSO TESTED FOR HCV RNA AND IT WAS NEGATIVE. THE UNITS OF MEASURE USED FOR THE ANTU AND SNIBE METHODS WERE NOT PROVIDED. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A REACTIVE RESULT WHEN TESTED WITH THE ELECSYS ANTI-HCV METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187507 ↗
• MalfunctionMay 4, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FROM THE COBAS E 402 ANALYTICAL UNIT AND A COBAS E 801 ANALYZER FOR ONE PATIENT. ON (B)(6) 2026: THE INITIAL RESULT WAS 31.3 COI (REACTIVE). THE REPEAT RESULT WAS 31.4 COI (REACTIVE). ON (B)(6) 2026: THE REPEAT RESULT FROM THE FUJIREBIO HCV SCORE, WHICH USES THE LINE IMMUNOASSAY (LIA) LABORATORY METHOD, WAS NEGATIVE. ON (B)(6) 2026: THE PATIENT SAMPLE WAS SENT TO THE INVESTIGATION LABORATORY. THE REPEAT RESULT ON AN E801 ANALYZER WAS 32.6 COI (REACTIVE). THE REPEAT RESULT WAS 32.9 COI (REACTIVE). THE REPEAT RESULT FROM AN ANALYZER THAT USES THE CHEMILUMINESCENCE IMMUNOASSAY (CLIA) LABORATORY METHOD WAS 0.19 (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068412 ↗
• MalfunctionApr 28, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE PATIENT WAS TESTED BEFORE DIALYSIS. THE INITIAL RESULT WAS 22.3 COI (REACTIVE). THE REPEAT RESULT USING A SYSMEX DEVICE WAS 0.39 COI (NON-REACTIVE). THE REPEAT RESULT USING AN ABBOTT DEVICE WAS 0.39 COI (NON-REACTIVE). THE PATIENT'S HCV RNA TEST RESULT WAS NEGATIVE. AT A LATER UNKNOWN DATE, THE SAMPLE WAS REPEATED ON ANOTHER COBAS E801 ANALYZER, AND THE RESULT WAS "THE SAME AS BEFORE." NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020963 ↗
• MalfunctionApr 28, 2026False Positive Result; Improper or Incorrect Procedure or Method

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE POSITIVE ELECSYS ANTI-HCV II RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 22.9 COI (REACTIVE). ON (B)(6) 2026, A NEW SAMPLE WAS RECEIVED FOR THE PATIENT, AND THE RESULTS WERE 20 AND 22 COI (REACTIVE). DUE TO MEDICAL GUIDELINES, THE PATIENT WAS INSTRUCTED TO REPEAT TESTING IN TWO OTHER LABORATORIES, WHICH BOTH OBTAINED NEGATIVE RESULTS. THE CUSTOMER DID NOT HAVE THE REPORTS CORRESPONDING TO THE NEGATIVE RESULTS BUT BELIEVES THEY WERE TESTED USING AN ABBOTT ALINITY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020096 ↗
• MalfunctionApr 27, 2026False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT ELECSYS HBSAG II AND ELECSYS ANTI-HCV II ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THIS MEDWATCH IS FOR THE ELECSYS ANTI-HCV II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS HBSAG II ASSAY. PATIENT SAMPLE 1: THE INITIAL RESULT FROM THE ANALYZER WAS 33.89 COI (REACTIVE). THE FIRST REPEAT RESULT FROM A MINI VIDAS SYSTEM WAS 0.06*. THE UNIT OF MEASUREMENT AND/OR INTERPRETATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002385 ↗
• MalfunctionApr 17, 2026False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE REACTIVE ELECSYS ANTI-HCV II RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. PATIENT RESULTS IN (B)(6) 2025 WERE 48 COI AND 49 COI, BOTH REACTIVE. THE SAME SAMPLE WAS MEASURED USING COMPETITOR METHODS. THE CMIA RESULT WAS NEGATIVE. THE HCV RIBA IMMUNOBLOT WAS NEGATIVE. THE HCV RNA QUANTITATIVE METHOD WAS NEGATIVE. A NEW SAMPLE ON (B)(6) 2026 TESTED ON THE E 801 ANALYZER HAD THE RESULT OF 54 COI (REACTIVE). THE SAMPLE WAS TESTED USING THE CMIA AND THE RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914463 ↗
• MalfunctionApr 17, 2026False Positive Result

  THERE WAS AN ALLEGATION OF FALSE-POSITIVE ELECSYS ANTI-HCV II RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 1.99 COI, AND THE REPEATED RESULTS WERE 1.99 COI AND 1.98 COI (ALL POSITIVE). ON (B)(6) 2026, THE SAMPLE WAS RETESTED ON ANOTHER MODULE (COBAS E 411), AND THE RESULTS WERE 1.88 COI AND 1.820 COI (BOTH POSITIVE). THE SAMPLE WAS TESTED USING THE CLIA ASSAY, AND THE RESULT WAS 0.10 (NEGATIVE). THE UNIT OF MEASURE WAS NOT PROVIDED. ON (B)(6) 2026, CONFIRMATION TESTING, USING THE LIA ASSAY (FUJIREBIO HCV SCORE), WAS PERFORMED WITH IMMUNOBLOT, AND THE RESULT WAS NEGATIVE. BASED ON THE PATIENT'S CLINICAL BACKGROUND, THE POSITIVE ANTI-HCV RESULTS ARE ALLEGEDLY FALSE-POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913709 ↗
• MalfunctionApr 13, 2026False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 22.3 COI (POSITIVE). THE PATIENT QUESTIONED THE INITIAL RESULT. ON (B)(6) 2026: THE ELECSYS ANTI-HCV II RESULT WAS 26.0 COI (POSITIVE). IT IS UNCLEAR IF A NEW SAMPLE WAS DRAWN AND TESTED OR IF THE ORIGINAL SAMPLE WAS REPEATED. A QUESTION WAS ASKED FOR CLARIFICATION, BUT NO ANSWER WAS PROVIDED. HCV RNA (TIANLONG, GENTIER 96E) TEST RESULT: < 50 IU/ML (NEGATIVE). ABBOTT AHCV RESULT: 0.07 S/CO (TESTED AT ANOTHER HOSPITAL AND INTERPRETED AS NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864149 ↗

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