Elecsys Anti-HCV II 08837031190Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613336166970), received between May 17, 2024 and Sep 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737228 ↗
• MalfunctionOct 29, 2025False Positive Result; Improper or Incorrect Procedure or Method; False Positive Result; Improper or Incorrect Procedure or Method

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO TWO COMPETITOR ANALYZERS. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE E801 ANALYZER RESULT WAS 2.19 COI AND THE REPEAT RESULT WAS 2.38 COI, BOTH INTERPRETED AS REACTIVE. THE YHLO ANALYZER RESULT WAS 0.17 COI, INTERPRETED AS NON-REACTIVE. THE ABBOTT ANALYZER RESULT WAS 0.13 S/CO. THE YHLO ANALYZER RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416582 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT POSITIVE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS COBAS E 200 V2 ASSAY ON THE COBAS 6000 E601 MODULE. THE INITIAL ROCHE RESULTS WERE REACTIVE WITH A VALUE OF 28 COI, OBTAINED FROM TWO SEPARATE RUNS USING TWO DIFFERENT SAMPLES. TESTING OF THE SAME SAMPLE ON THE SIEMENS ATTELICA SYSTEM YIELDED A NEGATIVE RESULT. NO WESTERN BLOT RESULT WAS AVAILABLE. FURTHER INVESTIGATION INCLUDED TESTING THE SAMPLE ON A COBAS E 602 MODULE WITH THE ANTI-HCV II REAGENT, WHICH PRODUCED A REACTIVE RESULT OF 25.34 COI. ADDITIONAL TESTING WITH THE FUJIREBIO INNOLIA HCV SCORE ASSAY YIELDED A CLEAR NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100145 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT REACTIVE RESULTS WITH THE ANTI-HCV G2 ELECSYS COBAS E 200 V2 ASSAY ON THE COBAS 6000 E601 MODULE. A PATIENT SAMPLE TESTED REACTIVE FOR ANTI-HCV II WITH A RESULT OF 10.08 COI. THIS WAS A FOLLOW-UP SAMPLE COLLECTED ONE YEAR AFTER A PREVIOUS SAMPLE FROM THE SAME PATIENT, WHICH HAD BEEN REPORTED AS INDETERMINATE IN AN IMMUNOBLOT ASSAY. ADDITIONALLY, A MICROBIOLOGY EXTERNAL QUALITY ASSESSMENT SCHEME (EQAS) SAMPLE TESTED REACTIVE FOR ANTI-HCV II WITH A RESULT OF 12.61 COI ON THE COBAS 6000 E601 MODULE. THE SAME EQAS SAMPLE TESTED NON-REACTIVE (0.08 INDEX) ON COMPETITOR INSTRUMENTS, INCLUDING ABBOTT AND OCD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095381 ↗
• MalfunctionSep 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT REACTIVE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-HCV II ASSAY ON THE COBAS E 602 MODULE. ON (B)(6) 2024, THE ELECSYS ANTI-HCV II ASSAY GENERATED A REACTIVE RESULT OF 119.5 COI FOR THE PATIENT SAMPLE. NO FLAGS OR ALARMS WERE REPORTED, AND THE SAMPLE WAS NOT DILUTED. SUBSEQUENT GENOMIC TESTING PRODUCED AN INDETERMINATE RESULT WITH AN NS3 BAND. TESTING WITH THE ABBOTT ANTI-HCV ASSAY ON THE ARCHITECT I 1000SR AT TWO DIFFERENT HOSPITALS YIELDED NEGATIVE RESULTS. RNA TESTING FOR HCV USING THE COBAS E 5800 SYSTEM ALSO PRODUCED A NEGATIVE RESULT. THE PATIENT WAS IDENTIFIED AS A DIALYSIS PATIENT WITH NO CLINICAL EVIDENCE OR HISTORY OF A HEPATITIS C INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070580 ↗
• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A FALSE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS COBAS E 200 V2 ASSAY ON THE COBAS 6000 E601 MODULE. ADDITIONALLY, AN EXTERNAL CONTROL (PROGBA) WAS TESTED AND GENERATED A REACTIVE RESULT ON ROCHE INSTRUMENTS, WHICH WAS EXPECTED TO BE NON-REACTIVE. THE PATIENT SAMPLE WAS INITIALLY TESTED ON (B)(6) 2021 USING THE COBAS 6000 E601 MODULE AND GENERATED A REACTIVE RESULT. THE SAME SAMPLE WAS TESTED ON THE ABBOTT ARCHITECT SYSTEM ON THE SAME DATE AND GENERATED A NEGATIVE RESULT. ON (B)(6) 2021, THE SAMPLE WAS RETESTED ON THE COBAS 6000 E601 MODULE AND AGAIN GENERATED A REACTIVE RESULT. IN (B)(6) 2021, A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED ON THE COBAS 6000 E601 MODULE AND GENERATED A REACTIVE RESULT. THE SAME SAMPLE WAS ALSO TESTED ON THE ABBOTT ARCHITECT SYSTEM AND GENERATED A REACTIVE RESULT. NO CONFIRMATORY TESTING BY IMMUNOBLOT WAS PERFORMED. TWO ADDITIONAL SAMPLES FROM THE SAME PATIENT, COLLECTED ON (B)(6) 2022, WERE TESTED ON THE COBAS E 602 MODULE USING THE ANTI-HCV II REAGENT AND GENERATED REACTIVE RESULTS OF 1.75 COI AND 1.86 COI. THESE SAMPLES WERE ALSO TESTED USING THE FUJIREBIO INNOLIA HCV SCORE ASSAY, WHIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067089 ↗
• MalfunctionAug 21, 2025Material Integrity Problem; Material Integrity Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE ELECSYS ANTI-HCV II RESULTS FROM THE COBAS 6000 E601 MODULE. THE RESULTS WERE 35- 40 COI (REACTIVE), AND WHEN REPEATED BY THE ABBOTT METHOD, THE RESULTS WERE NEGATIVE. ONE EXAMPLE WAS AN INITIAL RESULT OF 92.82 COI (REACTIVE). THE REPEAT RESULT WAS 92.82 COI (REACTIVE). ON (B)(6) 2025, THE REPEAT RESULTS WERE 89.32 COI (REACTIVE) AND 78.66 COI (REACTIVE). ON (B)(6) 2025, THE REPEAT RESULT USING THE ABBOTT METHOD WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858245 ↗
• MalfunctionJun 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV G2 (ANTI-HCV II) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER WHEN COMPARED TO A COMPETITOR'S PLATFORM (ABBOTT). INITIAL RESULT: 0.073 COI WHICH WAS INTERPRETED AS NON-REACTIVE (NEGATIVE). 1ST REPEAT RESULT: 0.67 S/CO (TESTED ON THE ABBOTT PLATFORM AND INTERPRETED AS NON-REACTIVE/NEGATIVE). 2ND REPEAT RESULT: 0.123 COI WHICH WAS INTERPRETED AS NON-REACTIVE (NEGATIVE). 3RD REPEAT RESULT: 0.97 S/CO (TESTED ON THE ABBOTT PLATFORM AND INTERPRETED AS NON-REACTIVE/NEGATIVE). 4TH REPEAT RESULT: 0.070 COI WHICH WAS INTERPRETED AS NON-REACTIVE (NEGATIVE). 5TH REPEAT RESULT: 1.47 S/CO (TESTED ON THE ABBOTT PLATFORM AND INTERPRETED AS REACTIVE). THE SAMPLE WAS THEN SENT TO ANOTHER SITE AND TESTED ON A SIEMENS PLATFORM AND THE 6TH REPEAT RESULT WAS CONSISTENT WITH ROCHE'S RESULTS. THE CUSTOMER EXPECTED A POSITIVE RESULT FOR THE PATIENT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509841 ↗
• MalfunctionMay 17, 2024False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS ANTI-HCV G2 (ANTI-HCV II) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. SAMPLE 1 (PATIENT 2): PATIENT 2 WAS DIAGNOSED POSITIVE FOR ANTI-HCV IN 2019. ON (B)(6) 2024, A SAMPLE WAS DRAWN AND TESTED ON COBAS E411 AND THE INITIAL RESULT WAS 0.092 COI (NEGATIVE). THE SAMPLE WAS REPEATED ON THE SAME DAY ON THE COBAS E411 AND THE REPEAT RESULT WAS 0.093 COI (NEGATIVE). THE ORIGINAL SAMPLE WAS SENT TO A DIFFERENT LABORATORY EQUIPPED WITH THE COBAS PRO SYSTEM BUT THE RESULTS HAVE NOT BEEN PROVIDED YET. SAMPLE 2 (PATIENT 1): ON (B)(6) 2024, A SAMPLE WAS INITIALLY TESTED ON A COMPETITOR'S (ALINITY) ANALYZER AND OBTAINED A RESULT OF 3.45 COI. ON (B)(6) 2024, A NEW SAMPLE WAS DRAWN AND TESTED ON COBAS E411 AND OBTAINED THE RESULT OF 0.10 COI (NEGATIVE). THE SAMPLE WAS REPEATED ON THE SAME DAY ON THE COBAS E411 AND THE REPEAT RESULT WAS 0.098 COI (NEGATIVE). THIS NEW SAMPLE WAS THEN SENT TO A DIFFERENT LABORATORY AND OBTAINED A POSITIVE RESULT. THE EXACT RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345781 ↗