Elecsys Anti-HCV II 08836981190Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613336166956), received between Jun 13, 2023 and Apr 27, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (20 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 31 reports, in the reporter's own words as published by the FDA.

• 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 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 7, 2026False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 2 PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT SAMPLES 1 AND 2'S HISTORICAL ANTI-HCV RESULTS WERE "NEGATIVE". THE ELECSYS ANTI-HCV II RESULTS WERE "POSITIVE". THE CONFIRMATORY RESULTS FROM A SERVICE LABORATORY WERE "POSITIVE." THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799466 ↗
• MalfunctionApr 3, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 3 TO 4 PATIENT SAMPLES A WEEK TESTED ON THE COBAS E 601 MODULE. THREE PATIENT SAMPLES WITH DISCREPANT RESULTS WERE PROVIDED: PATIENT SAMPLE 1 ON (B)(6) 2026, THE INITIAL RESULT FROM THE MODULE WAS 6.53 COI (REACTIVE). THE REPEAT RESULT FROM AN ABBOTT ALINITY ANALYZER WITH CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) LABORATORY METHOD WAS "NON-REACTIVE". PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE MODULE WAS 7.41 COI (REACTIVE). ON (B)(6) 2026, THE REPEAT RESULT FROM AN ABBOTT ALINITY ANALYZER WITH THE CMIA LABORATORY METHOD WAS "NON-REACTIVE". PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE MODULE WAS 8.71 COI (REACTIVE). ON (B)(6) 2026, THE REPEAT RESULT FROM AN ABBOTT ALINITY ANALYZER WITH THE CMIA LABORATORY METHOD WAS "NON-REACTIVE". THE DOCTORS QUESTIONED THE RESULTS, PROMPTING THE RERUNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781835 ↗
• MalfunctionFeb 18, 2026False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-HCV II RESULT FROM THE COBAS 6000 E601 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 2.16 COI (REACTIVE), ACCOMPANIED BY AN ALARM THAT THE REAGENT WAS EXPIRED. THE REPEAT RESULT WITH A NEW REAGENT CASSETTE WAS 2.34 COI (REACTIVE). A NEW SAMPLE WAS COLLECTED AND SENT TO AN EXTERNAL LABORATORY USING AN ARCHITECT ANALYZER, WITH A RESULT OF 0.09 COI (NEGATIVE). THE POLYMERASE CHAIN REACTION (PCR) RESULT WAS NEGATIVE, <15. THE UNIT OF MEASUREMENT WAS REQUESTED BUT NOT PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376917 ↗
• MalfunctionFeb 16, 2026False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HCV II ON A COBAS 6000 E601 MODULE. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. IT OCCURRED IN (B)(6) 2025. THE PATIENT'S SAMPLE RESULTED IN AN ANTI-HCV VALUE OF 5.36 COI (REACTIVE). THE SAMPLE WAS TESTED USING AN UNKNOWN COMPETITOR METHOD ON AN UNKNOWN DATE AND THE ANTI-HCV RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344479 ↗
• MalfunctionJan 15, 2026False Negative Result; Improper or Incorrect Procedure or Method

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE ELECSYS AHCV II RESULT WAS NON-REACTIVE. THE PATIENT'S RESULT USING A COMPETITOR'S METHOD (UNSPECIFIED) WAS REACTIVE. THE NON-REACTIVE RESULT WAS REPORTED TO THE PATIENT. RNA HCV TESTING AND/OR IMMUNOBLOT TESTING WERE NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082457 ↗
• MalfunctionDec 17, 2025False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR TWO PATIENTS FROM THE COBAS E411 RACK ANALYZER. THE CUSTOMER COULD NOT PROVIDE THE SPECIFIC DATE OF THE EVENT. AN ESTIMATION OF THE "END OF (B)(6)" WAS PROVIDED. THIS MEDWATCH IS FOR THE ELECSYS ANTI-HCV II ASSAY. REFER TO THE MEDWATCH WITH A1-PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS HIV COMBI PT ASSAY. THE CUSTOMER OBTAINED POSITIVE RESULTS FOR BOTH SAMPLES USING A COMPETITOR'S TESTS. THE SAMPLES WERE THEN TESTED ON THE COBAS E411 ANALYZER. EXAMPLE 1 ELECSYS ANTI-HCV II RESULT WAS NEGATIVE. THE SAMPLE WAS THEN POSITIVE WHEN TESTED USING PCR. EXAMPLE 2 ELECSYS HIV COMBI PT RESULT WAS NEGATIVE. THE RESULT FROM THE "AIDS CENTER" WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827635 ↗
• MalfunctionDec 10, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-HCV II RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 4.29 COI (REACTIVE). THE INSTRUMENT WAS RECALIBRATED, AND THE SAMPLE WAS RECENTRIFUGED, AND THE RESULT WAS 3.75 COI (REACTIVE). THE CONTROLS WERE RECHECKED, AND AN ADDITIONAL CENTRIFUGATION OF THE SAMPLE WAS CARRIED OUT, AND THE RESULT WAS 3.9 COI (REACTIVE). THE SAMPLE WAS TESTED USING DIFFERENT METHODS AND IN ANOTHER LABORATORY, AND IN BOTH CASES, THE RESULT WAS NEGATIVE. NO CONFIRMATORY TESTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766859 ↗
• MalfunctionNov 19, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 411 ANALYZERS COMPARED TO A COMPETITOR TEST. ON (B)(6) 2025, THE CUSTOMER TESTED THE PATIENT SAMPLE THREE TIMES AND THE RESULTS WERE 1.03 COI, 1.05 COI, AND 1.02 COI, ALL INTERPRETED AS POSITIVE. THE CUSTOMER QUESTIONED THE POSITIVE RESULTS AND SENT THE SAMPLE TO ANOTHER LABORATORY FOR TESTING. ON (B)(6) 2025, THE SAMPLE WAS TESTED AT THE SECOND LABORATORY THREE TIMES AND THE RESULTS WERE 1.03 COI, 0.997 COI, AND 1.02 COI, ALL INTERPRETED AS POSITIVE. THE SAMPLE WAS ALSO TESTED USING A FUJIREBIO IMMUNOBLOT TEST AND THE RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597072 ↗
• MalfunctionNov 19, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS WITH TWO PATIENT SAMPLES TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM) COMPARED TO A COMPETITOR METHOD. SAMPLE 1 (B)(6) 2025): THE INITIAL RESULT WAS 0.066 COI (NON-REACTIVE). THE REPEAT RESULT USING THE VIDAS SYSTEM WAS REACTIVE. THE SAMPLE WAS REPEATED 5-6 TIMES AND THE RESULTS WERE CONSISTENT EACH TIME. SAMPLE 2 (B)(6) 2025): THE INITIAL RESULT WAS 21.85 COI (REACTIVE). THE REPEAT RESULT WAS 21.3 COI (REACTIVE). THE REPEAT RESULT USING THE VIDAS SYSTEM WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594551 ↗
• MalfunctionOct 27, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II ASSAY RESULTS WITH TWO SAMPLES FROM THE SAME PATIENT TESTED ON A COBAS 6000 E601 MODULE. FIRST SAMPLE MEASURED ON (B)(6) 2025: THE INITIAL RESULT WAS 1.4 COI (REACTIVE). THE REPEAT RESULT WAS 1.4 COI (REACTIVE). THE SAMPLE WAS REPEATED AT A DIFFERENT LABORATORY USING A DIFFERENT ASSAY AND THE RESULT WAS ANTI-HCV NEGATIVE. SECOND SAMPLE MEASURED ON (B)(6) 2025: THE INITIAL RESULT WAS 2.45 COI (REACTIVE). THE REPEAT RESULT WAS 2.42 COI (REACTIVE). THE SAMPLE WAS REPEATED AT A DIFFERENT LABORATORY FOR HCV RNA (QUANTITATIVE) TESTING AND THE RESULT WAS NEGATIVE: <0.01 KIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393337 ↗
• MalfunctionOct 22, 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 TWO COBAS E411 ANALYZERS. THE SAMPLE WAS FIRST TESTED ON THE CUSTOMER'S E411 ANALYZER, RESULTING IN ANTI-HCV VALUES OF 0.916 COI (BORDERLINE) AND 0.926 COI (BORDERLINE). THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E411 ANALYZER, RESULTING IN ANTI-HCV VALUES OF 0.952 COI (BORDERLINE) AND 0.964 COI (BORDERLINE). THE SAMPLE WAS TESTED USING AN UNKNOWN CLIA METHOD, RESULTING IN AN ANTI-HCV VALUE OF 0.65 (NEGATIVE). THE SPECIFIC UNIT OF MEASURE IS NOT KNOWN. THE SAMPLE WAS TESTED USING THE FUJIREBIO HCV SCORE ASSAY, RESULTING IN A BORDERLINE ANTI-HCV VALUE (C2: 1+).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359940 ↗
• MalfunctionOct 15, 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 411 ANALYZER (DISK SYSTEM). NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE RESULTED IN AN ANTI-HCV VALUE OF 33 (REACTIVE) WHEN TESTED ON THE E411 ANALYZER. THE SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER, RESULTING IN A NEGATIVE VALUE. THE SAMPLE WAS ALSO REPEATED ON A VIDAZ ANALYZER, RESULTING IN A NEGATIVE VALUE. WHEN PCR TESTING WAS PERFORMED ON THE SAMPLE ,THE ANTI-HCV RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295806 ↗
• MalfunctionSep 19, 2025False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  "THE INITIAL REPORTER ALLEGED DISCREPANT REACTIVE RESULTS FOR ONE PATIENT SAMPLE TESTED USING THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS 6000 E601 MODULE. IN (B)(6) 2023, THE PATIENT SAMPLE WAS TESTED USING THE ELECSYS AHCV II ASSAY AND GENERATED A REACTIVE RESULT OF 2 COI. A RE-RUN OF THE SAME SAMPLE CONFIRMED THE INITIAL REACTIVE RESULT. TESTING OF THE SAME PATIENT SAMPLE AT A DIFFERENT LABORATORY USING THE ABBOTT AHCV ASSAY PRODUCED A NON-REACTIVE RESULT (DATE NOT PROVIDED). SUBSEQUENT TESTING OF THE PATIENT SAMPLE USING THE ELECSYS AHCV II ASSAY AGAIN GENERATED A REACTIVE RESULT (DATE NOT PROVIDED)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100335 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT NEGATIVE RESULT FOR THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY COMPARED TO A POSITIVE RESULT OBTAINED USING AN ABBOTT SYSTEM. ON 23-MAY-2023, THE CUSTOMER REPORTED A RESULT OF 0.062 COI (NEGATIVE) FOR THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY. ON THE SAME DATE, THE ABBOTT SYSTEM REPORTED A RESULT OF 1.8 S/CO (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100326 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT POSITIVE RESULT WITH THE ELECSYS ANTI-HCV II2 ASSAY ON A COBAS E 411 ANALYZER. THE INITIAL RESULT WAS 100 COI (REACTIVE). ADDITIONAL TESTING WAS CONDUCTED AT THE CUSTOMER SITE AND INCLUDED CHEMILUMINESCENT ENZYME IMMUNOASSAY (CLEIA) AND POLYMERASE CHAIN REACTION (PCR), BOTH OF WHICH WERE NEGATIVE. REPEAT TESTING ON THE COBAS E 411 ANALYZER YIELDED RESULTS OF 100.6 COI AND 102.1 COI (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100150 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE POSITIVE ANTI-HCV RESULT FOR A PATIENT SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS 6000 E601 MODULE. ON (B)(6) 2025, THE SAMPLE WAS TESTED FOR ANTI-HCV AND YIELDED A RESULT OF 34.82 COI (REACTIVE). A RE-EXAMINATION OF THE PRIMARY SAMPLE ON THE SAME DAY PRODUCED A RESULT OF 34.66 COI (REACTIVE). ON (B)(6) 2025, A NEW BLOOD SAMPLE WAS TESTED FOR ANTI-HCV AND HCV RNA. THE ANTI-HCV RESULT WAS 31.29 COI (REACTIVE). A REPEAT TEST USING ULTRACENTRIFUGATION AT 10,000 RPM YIELDED A RESULT OF 30.85 COI (REACTIVE). HCV RNA TESTING ON THE GEN EXPERT ANALYZER SHOWED THAT HCV RNA WAS NOT DETECTED. CONFIRMATION TESTING WAS PERFORMED USING THE ABBOTT ANALYZER FOR ANTI-HCV, WHICH PRODUCED A NON-REACTIVE RESULT, AND THE COBAS 6800 SYSTEM FOR HCV RNA, WHICH ALSO SHOWED THAT HCV RNA WAS NOT DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098329 ↗
• MalfunctionSep 18, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT POSITIVE RESULT FOR THE ELECSYS ANTI-HCV II ASSAY ON THE COBAS 6000 E601 MODULE WHEN COMPARED TO A NEGATIVE RESULT OBTAINED USING AN ABBOTT ASSAY. THE ELECSYS ANTI-HCV II ASSAY GENERATED A POSITIVE RESULT, WHILE THE ABBOTT ASSAY GENERATED A NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089120 ↗
• MalfunctionSep 18, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED THREE FALSE POSITIVE RESULTS FOR THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS E411 DISK ANALYZER. BETWEEN 20-DEC-2023 AND 10-JAN-2025, 357 SAMPLES WERE TESTED FOR HEPATITIS C VIRUS (HCV) AT THE CUSTOMER SITE, AND THREE SAMPLES WERE IDENTIFIED AS FALSE POSITIVE. ON (B)(6) 2025, THE THREE SAMPLES WERE RETESTED ON A COBAS E 801 ANALYZER. SAMPLE (B)(6) GENERATED A RESULT OF 2.96 COI (REACTIVE), SAMPLE (B)(6) GENERATED A RESULT OF 1.89 COI (REACTIVE), AND NO RESULT WAS PROVIDED FOR SAMPLE (B)(6). SUBSEQUENT RNA TESTING FOR ALL THREE SAMPLES WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081532 ↗
• MalfunctionSep 18, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT POSITIVE RESULT WITH THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS E411 RACK INSTRUMENT. THE SAMPLE IN QUESTION TESTED POSITIVE WITH THE ELECSYS ANTI-HCV II ASSAY. ADDITIONAL TESTING INCLUDED ABBOTT ANTI-HCV (AHCV) AND POLYMERASE CHAIN REACTION (PCR), BOTH OF WHICH WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081530 ↗
• MalfunctionSep 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A FALSE POSITIVE ANTI-HCV RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL ANTI-HCV RESULT WAS 44 COI (REACTIVE). A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED AND YIELDED A RESULT OF 46.26 COI (REACTIVE). ADDITIONAL TESTING INCLUDED ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA), WHICH WAS NON-REACTIVE, AND HEPATITIS C VIRUS (HCV) RNA TESTING, WHICH WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070669 ↗
• MalfunctionSep 17, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE NEGATIVE ANTI-HCV G2 ELECSYS COBAS E 100 V2 RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. ON (B)(6) 2025, THE SAMPLE WAS TESTED ON THE COBAS 6000 E601 MODULE AND GENERATED A NEGATIVE RESULT OF (B)(4) COI. THE SAMPLE WAS RETESTED THE FOLLOWING DAY ON THE SAME INSTRUMENT AND AGAIN GENERATED A NEGATIVE RESULT OF (B)(4) COI. THE SAMPLE WAS ALSO TESTED ON A COBAS E 411 ANALYZER USING A DIFFERENT REAGENT LOT AND GENERATED A NEGATIVE RESULT. HOWEVER, WHEN THE SAME SAMPLE WAS TESTED ON A COMPETITOR INSTRUMENT, VIDAS (ENZYME-LINKED FLUORESCENT ASSAY [ELFA] METHOD), THE RESULT WAS POSITIVE. THE PATIENT REPORTEDLY HAD A PREVIOUS POSITIVE ANTI-HCV RESULT IN 2017 USING THE ELECSYS ANTI-HCV ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070667 ↗
• MalfunctionSep 16, 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 100 V2 ASSAY ON THE COBAS 6000 E601 MODULE AND THE COBAS E 411 ANALYZER. ON (B)(6) 2022 AT 09:18, THE SAMPLE WAS TESTED ON THE COBAS 6000 E601 MODULE AND GENERATED A RESULT OF 3.94 COI (REACTIVE). ON (B)(6) 2022 AT 10:05, THE SAME SAMPLE WAS TESTED ON THE COBAS E 411 ANALYZER AND GENERATED A RESULT OF 3.44 COI (REACTIVE). TESTING OF THE SAME SAMPLE ON THE ABBOTT ALINITY SYSTEM YIELDED A RESULT OF 0.45 S/CO (NEGATIVE). THE RESULTS WERE NOT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067256 ↗
• MalfunctionSep 16, 2025False Negative Result; Low Test Results; Non Reproducible Results; False Negative Result; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A FALSE NEGATIVE RESULT FOR THE ANTI-HCV G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS E411 RACK ANALYZER. ON (B)(6)2024, A PATIENT SAMPLE INITIALLY GENERATED A RESULT OF 0.31 COI (NON-REACTIVE), WHICH WAS NOT REPORTED. THE SAME SAMPLE WAS RETESTED ON (B)(6)2024 AND GENERATED A RESULT OF 203.9 COI (REACTIVE), WHICH WAS REPORTED AS IT ALIGNED WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062711 ↗