Elecsys Anti-HCV II 08837058190Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07613336166994), received between Jan 12, 2023 and Sep 30, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (29 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 44 reports, 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 ↗
• 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 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 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 1, 2026False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV II ASSAY AT A "TRANSFERRED" HOSPITAL. THE PATIENT WAS INITIALLY TESTED AT THE CUSTOMER'S SITE USING ABBOTT AND SIEMENS, BOTH RESULTING IN ANTI-HCV VALUES OF 0.1 COI (NEGATIVE). THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL, AND THE SAMPLE WAS TESTED USING THE ELECSYS ANTI-HCV II ASSAY ON AN UNKNOWN ANALYZER, RESULTING IN A VALUE OF 9.61COI (POSITIVE). THE PATIENT WAS THEN RETURNED TO THE CUSTOMER'S SITE, WHERE THE FOLLOWING TESTS TOOK PLACE: THE ORIGINAL SAMPLE WAS REPEATED, AND THE REPEAT RESULT WAS NEGATIVE. A NEW SAMPLE WAS DRAWN AND TESTED, AND THE RESULT WAS NEGATIVE. HCV-RNA (NUCLEIC ACID TEST) WAS PERFORMED, AND THE RESULT WAS NOT DETECTED (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753294 ↗
• MalfunctionMar 25, 2026False Positive Result; Improper or Incorrect Procedure or Method; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS E 402 ANALYTICAL UNIT. THE ELECSYS ANTI-HCV II: 106 COI (POSITIVE). SIEMENS: POSITIVE. VIDAS BIOMERIEUX: 0.88 COI (NEGATIVE). IMMUNOBLOT RIBA: NEGATIVE (NEGATIVE). HCV-RNA: NOT DETECTED. NO ERRONEOUS RESULT WAS REPORTED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686344 ↗
• MalfunctionMar 3, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE REACTIVE ELECSYS ANTI-HCV II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: THE ELECSYS ANTI-HCV RESULT WAS 8.37 COI (REACTIVE). ON (B)(6) 2026, THE SAMPLE WAS REPEATED, AND THE RESULT WAS 8.94 COI (REACTIVE). THE SAMPLE WAS TESTED AT ANOTHER FACILITY USING THE CHEMILUMINESCENCE METHODOLOGY, AND THE RESULT WAS 0.19 COI (NON-REACTIVE). THIS RESULT WAS BELIEVED TO BE CORRECT. SAMPLE 2: ON (B)(6) 2026, THE ELECSYS ANTI-HCV RESULT WAS 8.64 COI (REACTIVE). ON (B)(6) 2026, THE SAMPLE WAS REPEATED, AND THE RESULT WAS 8.31 COI (REACTIVE). THE SAMPLE WAS TESTED AT ANOTHER FACILITY USING THE ELECTROCHEMILUMINESCENCE METHODOLOGY, AND THE RESULT WAS 0.18 COI (NON-REACTIVE). THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493694 ↗
• MalfunctionFeb 13, 2026High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS ANTI-HCV II ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE FROM (B)(6) 2026 AND THE SECOND SAMPLE FROM (B)(6) 2026 BOTH HAD POSITIVE ANTI-HCV RESULTS WHEN TESTED ON THE E 801 ANALYZER. BOTH SAMPLES WERE NEGATIVE WHEN TESTED WITH THE SIEMENS ATELLICA METHOD. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE TESTED ON THE E 801 ANALYZER TWICE ON 02-(B)(6) 2026, RESULTING IN VALUES OF 39.4 COI (REACTIVE) AND 39.4 COI (REACTIVE). IT WAS ASKED, BUT IT IS NOT KNOWN IF THESE MEASUREMENTS WERE PERFORMED WITH ONE OF THE TWO PATIENT SAMPLES OR IF THEY WERE MEASUREMENTS PERFORMED WITH A SAMPLE FROM A DIFFERENT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333412 ↗
• MalfunctionFeb 11, 2026False Positive Result

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT POSITIVE RESULT FOR 1 TESTED FOR ELECSYS ANTI-HCV II (ANTI-HCV II) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE E801 ANALYZER WAS 14.7 COI (POSITIVE). THE REPEAT RESULT FROM THE E801 ANALYZER WAS 15.0 COI (POSITIVE). ON (B)(6) 2026, THE RESULT FROM THE ABBOTT ALINITY METHOD WAS 0.99 S/CO (NEGATIVE). ON (B)(6) 2026, THE HCV RNA RESULT FROM A COBAS 5800 WAS HCV TARGET NOT DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313220 ↗
• MalfunctionFeb 6, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR THREE SAMPLES FROM ONE PATIENT USING THE COBAS E 801 ANALYTICAL UNIT COMPARED TO HCV RNA (ROCHE) RESULTS. THE ANTI-HCV TEST AND THE HCV RNA TEST WERE PERFORMED USING DIFFERENT COLLECTION TUBES DRAWN AT THE SAME TIME. ON (B)(6) 2025, THE ANTI-HCV RESULT WAS 2.52 COI (POSITIVE). THE HCV RNA RESULT WAS NEGATIVE. ON (B)(6) 2025, THE ANTI-HCV RESULT WAS 3.67 COI (POSITIVE). THE HCV RNA RESULT WAS NEGATIVE. ON (B)(6) 2025, THE ANTI-HCV RESULT WAS 4.22 COI (POSITIVE). THE HCV RNA RESULT WAS NEGATIVE. THE HOSPITAL FOLLOWS A STANDARD RE-TESTING PROTOCOL FOR HCV IN THAT ANY SAMPLE THAT INITIALLY TESTS POSITIVE IS AUTOMATICALLY RERUN, AND IN THIS CASE, THE RESULTS SHOWED NO DISCREPANCY. NO SPECIFIC REPEAT RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280215 ↗
• MalfunctionFeb 4, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV II ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTED IN AN ANTI-HCV VALUE OF 1.42 COI (REACTIVE) WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS TESTED USING THE ABBOTT ALINITY METHOD, RESULTING IN AN ANTI-HCV VALUE OF 0.1 S/CO (NON-REACTIVE). THE SAMPLE WAS TESTED WITH AN HCV RNA TEST AND THE RESULT WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260434 ↗
• MalfunctionDec 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-HCV II (ANTI-HCV II) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 10.1 COI (POSITIVE). THE REPEAT RESULT WAS 9.92 COI (POSITIVE). THE REPEAT RESULT FROM AN UNSPECIFIED COMPETITOR METHOD WAS 0.35 C/CO (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850950 ↗
• MalfunctionDec 19, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT NEGATIVE RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ELECSYS ANTI-HCV II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: INITIAL RESULT: 0.0501 COL (INTERPRETED AS NEGATIVE). 1ST REPEAT RESULT: 3.24 COL (TESTED ON ALINITY AND INTERPRETED AS POSITIVE). 2ND REPEAT RESULT: 1.02 COL (TESTED ON ATELLICA AND INTERPRETED AS POSITIVE). RIBA BLOT (RECOMBINANT IMMUNOBLOT ASSAY) TEST RESULT WAS INDETERMINATE. PATIENT 2: INITIAL RESULT: 0.0456 COL (INTERPRETED AS NEGATIVE). 1ST REPEAT RESULT: 4.65 COL (TESTED ON ALINITY AND INTERPRETED AS POSITIVE). 2ND REPEAT RESULT: 0.63 COL (TESTED ON ATELLICA AND INTERPRETED AS NEGATIVE). RIBA BLOT (RECOMBINANT IMMUNOBLOT ASSAY) TEST RESULT WAS NEGATIVE. PATIENT 3: INITIAL RESULT: 0.0643 COL (INTERPRETED AS NEGATIVE). 1ST REPEAT RESULT: 3.85 COL (TESTED ON ALINITY AND INTERPRETED AS POSITIVE). 2ND REPEAT RESULT: 0.92 COL (TESTED ON ATELLICA AND INTERPRETED AS EQUIVOCAL). RIBA BLOT (RECOMBINANT IMMUNOBLOT ASSAY) TEST RESULT WAS INDETERMINATE. NO QUESTIONABLE RESULTS WERE REPORTED TO THE PATIENTS. THE 1ST REPEAT RESULTS WERE CONSIDERED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850488 ↗
• MalfunctionDec 18, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-HCV II (ANTI-HCV II) ON A COBAS E 402 ANALYTICAL UNIT. NOTE: THE UNIT OF MEASURE WAS NOT PROVIDED. THE INITIAL RESULT FROM THE E402 ANALYZER WAS 92.40 (POSITIVE). THE REPEAT RESULT WAS 92.90 (POSITIVE). THE SAMPLE WAS REPEATED AT A REFERENCE LABORATORY, WHERE THE RESULT FROM THE ABBOTT METHOD WAS "NEGATIVE." THE SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842561 ↗
• MalfunctionNov 25, 2025False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV II ON A COBAS E 801 ANALYTICAL UNIT AND AN UNKNOWN ROCHE ANALYZER. THE SAMPLE WAS INITIALLY RESTED ON THE CUSTOMER'S E 801 ANALYZER, RESULTING IN AN ANTI-HCV VALUE OF 53 COI (REACTIVE). THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING ON AN UNKNOWN DEVICE AND IT RESULTED IN AN ANTI-HCV VALUE OF 0.6 COI. THE SAMPLE WAS REPEATED ON THE CUSTOMER'S E 801 ANLAYZER ON (B)(6) 2025, RESULTING IN AN ANTI-HCV VALUE OF 59 COI (REACTIVE). THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON AN UNKNOWN ROCHE DEVICE ON (B)(6) 2025, RESULTING IN ANTI-HCV VALUES OF 62.3 COI (REACTIVE) AND 62.6 COI (REACTIVE). DURING INVESTIGATIONS, THE SAMPLE WAS ALSO TESTED USING AN UNKNOWN CLIA METHOD, RESULTING IN AN ANTI-HCV VALUE OF 0.69 S/CO (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643673 ↗
• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-HCV II RESULT WITH A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 4.27 COI (REACTIVE). THE REPEAT RESULT ON THE YHLO PLATFORM WAS 0.48 COI. THE REPEAT RESULT ON THE ABBOTT PLATFORM WAS 0.16 S/COI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450365 ↗
• MalfunctionOct 28, 2025False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-HCV II RESULT FROM THE COBAS 8000 E 801 MODULE FOR ONE PATIENT. THE SAMPLE YIELDS A REPEATED REACTIVE RESULT, BUT ON ANOTHER ROCHE ANALYZER, IT GIVES A NEGATIVE RESULT. THE INITIAL RESULT WAS 1.16 COI (REACTIVE). THE SECOND RESULT WAS 1.17 COI (REACTIVE). THE THIRD RESULT WAS 1.16 COI (REACTIVE). THE RESULT ON ANOTHER ROCHE ANALYZER WAS 0.769 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402639 ↗
• MalfunctionOct 27, 2025False Positive Result; False 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. INITIAL RESULT: 0.963 COI. SINCE THE INITIAL RESULT WAS IN THE BORDERLINE ZONE, IT PROMPTED THE REPEAT OF THE SAMPLE (BY TRIGGERING THE E-FLOW REPETITION). 1ST REPEAT RESULT: 0.948 COI. 2ND REPEAT RESULT: 0.929 COI. THE CUSTOMER PERFORMED THE NUCLEIC ACID TEST (NAT) TECHNIQUE FOR RIBONUCLEIC ACID (RNA) HCV, AND THE OUTCOME WAS NEGATIVE (NON-REACTIVE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393590 ↗
• MalfunctionOct 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV II ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTED IN ANTI-HCV VALUES OF 4.7 COI (REACTIVE) AND 4.66 COI (REACTIVE) WHEN TESTED ON THE E 801 SYSTEM. THE RESULTS WERE INCONSISTENT WITH THE PATIENT'S HISTORICAL RESULTS. THE SAMPLE WAS REPEATED ON TWO COMPETITOR DEVICES. WHEN TESTED ON A YHLO INSTRUMENT, THE ANTI-HCV RESULT WAS 0.01 COI (NEGATIVE). WHEN TESTED ON THE ABBOTT PLATFORM, THE ANTI-HCV RESULT WAS 0.06 S/CO (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323817 ↗