Elecsys Anti-HCV II 07026889190Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04015630939947), received between Sep 5, 2018 and May 15, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (16 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 26 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 17, 2025False Positive Result; High Test Results; False Positive Result; High Test 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. THE CUSTOMER STATED THAT THE PATIENT SAMPLE INITIALLY RESULTED IN AN ANTI-HCV VALUE OF 3 COI (REACTIVE) AND IT REPEATED AS 3 COI (REACTIVE). SPECIFIC RAW DATA WAS PROVIDED FOR AN ANTI-HCV VALUE OF 3.4 COI (REACTIVE). THE SAMPLE WAS REPEATED USING THE ABBOTT ANTI-HCV METHOD ON (B)(6) 2025, RESULTING IN A VALUE OF 0.11 S/CO (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568399 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED THAT FALSE POSITIVE RESULTS WERE GENERATED WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT THROUGHOUT THE YEAR 2023. THE CUSTOMER REPORTED 10 SAMPLES FROM 10 DIFFERENT PATIENTS THAT WERE REPEATEDLY REACTIVE WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY BUT WERE NON-REACTIVE WHEN TESTED ON THE ABBOTT ARCHITECT SYSTEM. THE CUSTOMER CONSIDERS THESE RESULTS AS FALSE POSITIVES BASED ON THE COMPARISON TO ABBOTT ARCHITECT RESULTS. NO CONFIRMATION OF THE REACTIVE RESULTS WITH AN INDEPENDENT IMMUNOBLOT ANALYSIS WAS AVAILABLE. THE SAMPLES IN QUESTION WERE FROM NON-HEALTHY PATIENTS, ALL OF WHOM WERE ON MEDICATIONS. THE CUSTOMER INDICATED THE USE OF GEL SEPARATION TUBES (3.5 AND 4 ML) FOR SAMPLE COLLECTION BUT COULD NOT CONFIRM WHETHER THE SAMPLES WERE LIPEMIC, HEMOLYSATE, OR ICTERIC. SOME SAMPLES WERE NOTED TO SHOW HEMOLYSIS. FOUR OF THE 10 SAMPLES WERE AVAILABLE FOR FURTHER INVESTIGATION, BUT TWO OF THESE DID NOT MEET SAMPLE QUALITY SPECIFICATIONS DUE TO HEMOLYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100526 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A FALSE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-HCV II ASSAY ON THE COBAS PURE E 402 ANALYTICAL UNIT. THE PATIENT SAMPLE GENERATED A RESULT OF 19.10 CUT-OFF INDEX (COI) WITH THE ELECSYS ANTI-HCV II ASSAY. THE SAME SAMPLE WAS TESTED WITH THE DIASORIN METHOD AND FOUND TO BE NEGATIVE. NO IMMUNOBLOT OR POLYMERASE CHAIN REACTION (PCR) TESTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099752 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE POSITIVE RESULT WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT SAMPLE. ON (B)(6) 2024, THE ELECSYS ANTI-HCV II ASSAY GENERATED A RESULT OF 53.1 COI (POSITIVE) ON THE COBAS E 801 ANALYTICAL UNIT. TESTING OF THE SAME SAMPLE USING A GOLD LABEL METHOD PRODUCED A NEGATIVE RESULT. TESTING AT ANOTHER LABORATORY ON THE SAME DATE YIELDED A RESULT OF 47.1 COI (POSITIVE) WITH THE ELECSYS ANTI-HCV II ASSAY ON A COBAS E 801 ANALYTICAL UNIT, WHILE TESTING WITH THE ABBOTT ASSAY PRODUCED A RESULT OF 0.99 (NEGATIVE). NO ORIGINAL DATA WERE PROVIDED FOR THE ABBOTT OR GOLD LABEL METHODS. ON (B)(6) 2024, POLYMERASE CHAIN REACTION (PCR) TESTING OF THE SAMPLE PRODUCED A NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099314 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A FALSE POSITIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-HCV II ASSAY. ON (B)(6) 2021, THE PATIENT SAMPLE WAS TESTED WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY AND GENERATED A RESULT OF 13.4 COI (REACTIVE). A NEW BLOOD SAMPLE FROM THE SAME PATIENT WAS TESTED ON (B)(6) 2021, GENERATING A RESULT OF 10.8 COI (REACTIVE). ADDITIONAL TESTING OF THE SAMPLE FROM (B)(6) 2021 INCLUDED ABBOTT ARCHITECT, WHICH WAS NEGATIVE; AN ANTIBODY TEST (MONOLISA BIORAD ELISA), WHICH WAS NEGATIVE; AND AN IMMUNOBLOT (FUJIREBIO INNO-LIA), WHICH WAS NEGATIVE. POLYMERASE CHAIN REACTION (PCR) TESTING WAS ALSO NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098317 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE POSITIVE RESULT WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2021, THE SAMPLE INITIALLY MEASURED 1.85 COI (REACTIVE). A REPEAT TEST ON THE SAME SYSTEM YIELDED 1.90 COI (REACTIVE), AND A SUBSEQUENT TEST FROM PLASMA WITH EDTA RESULTED IN 2.61 COI (REACTIVE). THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR RE-MEASUREMENT USING A COMPETITOR ANALYZER, WHICH REPORTED A NON-REACTIVE RESULT OF 0.5 COI. FURTHER TESTING WAS CONDUCTED USING THE FUJIREBIO INNOLIA HCV SCORE ASSAY, WHICH PRODUCED A CLEAR NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098084 ↗
• MalfunctionSep 18, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT POSITIVE RESULT FOR THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2022, A PATIENT SAMPLE TESTED POSITIVE WITH A RESULT OF 16 COI, WHICH WAS REPEATED AND CONFIRMED. ON (B)(6) 2022, A NEW BLOOD SAMPLE WAS DRAWN, AND THE RESULT WAS 12.1 COI. SUBSEQUENT TESTING AT OTHER LABORATORIES USING AN IMMUNOLOGICAL TEST, LIKELY ON AN ABBOTT SYSTEM, YIELDED NEGATIVE RESULTS. IMMUNOBLOT TESTING FOR BOTH SAMPLES ALSO PRODUCED CLEAR NEGATIVE RESULTS. THE PATIENT DID NOT RECEIVE TREATMENT FOR HEPATITIS C VIRUS (HCV) BASED ON THE POSITIVE RESULTS, AS CLARIFIED BY THE ATTENDING DOCTORS. THE RESULTS WERE ULTIMATELY CONFIRMED TO BE FALSE POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088914 ↗
• MalfunctionSep 18, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A FALSE-POSITIVE RESULT FOR ONE SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER REPORTED RECEIVING A REACTIVE RESULT FOR THE SAMPLE. THE PATIENT WAS REDRAWN, AND THE SAMPLE WAS TESTED AT AN EXTERNAL LABORATORY (QUEST), WHERE THE RESULT WAS NON-REACTIVE. THE CUSTOMER'S WORKFLOW INVOLVES REPORTING REACTIVE ANTI-HCV RESULTS AND SENDING THE SAMPLE FOR CONFIRMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081534 ↗
• MalfunctionSep 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE POSITIVE RESULT FOR ONE SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE WAS INITIALLY MEASURED AS REACTIVE WITH THE ELECSYS ANTI-HCV II ASSAY, YIELDING A RESULT OF 125 COI (REACTIVE). THIS RESULT WAS CONFIRMED ON (B)(6) 2020. SUBSEQUENT TESTING AT THE CUSTOMER SITE USING WESTERN BLOT YIELDED A NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076894 ↗
• MalfunctionSep 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED DISCREPANT POSITIVE ANTI-HCV G2 ELECSYS E2G 300 RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS E 801 ANALYTICAL UNIT. FOR SAMPLE 1, THE ANTI-HCV RESULTS WERE 13.6 (DAUGHTER TUBE) AND 12.4 (MOTHER TUBE) AT UCH, AND 14.3 ON THE COBAS E 801. FOR SAMPLE 2, THE ANTI-HCV RESULTS WERE 8.77 (DAUGHTER TUBE) AND 8.69 (MOTHER TUBE) AT UCH, AND 8.58 ON THE COBAS E 801. TESTING OF THE SAME SAMPLES AT THE LOCAL GOVERNMENT REFERENCE LABORATORY (PHLC) USING COMPETITOR METHODS, INCLUDING MERUX, ORTHO-BLOT, AND VIDAS (BIOMERIEUX), YIELDED NEGATIVE ANTI-HCV RESULTS. POLYMERASE CHAIN REACTION (PCR) TESTING AT THE SAME REFERENCE LABORATORY ALSO DID NOT DETECT HCV RNA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075313 ↗
• MalfunctionSep 17, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT NEGATIVE RESULT FOR THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT SAMPLE. THE NEGATIVE RESULT WAS INCONSISTENT WITH THE PATIENT'S REPORTED HISTORY OF A PREVIOUS HEPATITIS C VIRUS (HCV) INFECTION. THE INITIAL TEST CONDUCTED ON (B)(6) 2023 USING THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY YIELDED A RESULT OF 0.0307 COI (NON-REACTIVE). A REPEAT TEST ON (B)(6) 2023 PRODUCED A RESULT OF 0.0310 COI (NON-REACTIVE). COMPETITOR TESTING OF THE SAME SAMPLE INCLUDED ABBOTT, WHICH YIELDED A RESULT OF 6.65 S/CO (REACTIVE), AND AUTOBIO, WHICH YIELDED A RESULT OF 1.935 S/CO (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075189 ↗
• MalfunctionSep 17, 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 E2G 300 ASSAY ON THE COBAS E 801 MODULE. THE INITIAL RESULT FOR THE SAMPLE WAS 34.5 COI (REACTIVE). A REPEAT TEST ON THE SAME SYSTEM YIELDED A RESULT OF 34.6 COI (REACTIVE). A SUBSEQUENT TEST USING PLASMA FROM THE SAME PATIENT GENERATED A RESULT OF 32.7 COI (REACTIVE). ADDITIONAL TESTING OF THE SAMPLE INCLUDED ABBOTT ALINITY, WHICH YIELDED A RESULT OF 0.14 S/CO (NEGATIVE), AND POLYMERASE CHAIN REACTION (PCR) FOR HEPATITIS C VIRUS (HCV) RNA, WHICH WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075113 ↗
• MalfunctionSep 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE POSITIVE RESULT FOR THE ELECSYS ANTI-HCV II ASSAY ON THE COBAS E 801 MODULE FOR ONE PATIENT SAMPLE. THE INITIAL SAMPLE, DRAWN ON (B)(6) 2020, YIELDED A REACTIVE RESULT OF 14.70 COI. A REPEAT TEST ON (B)(6) 2020 PRODUCED A REACTIVE RESULT OF 14.90 COI. A SECOND SAMPLE, DRAWN ON (B)(6) 2020, YIELDED A REACTIVE RESULT OF 8.59 COI. A THIRD SAMPLE, DRAWN ON (B)(6) 2020, YIELDED A REACTIVE RESULT OF 11.9 COI. ADDITIONAL TESTING WAS CONDUCTED USING VARIOUS METHODS. HCV VIRAL LOAD TESTING WITH THE ROCHE CAP/CTM METHOD REPORTED THE TARGET AS NOT DETECTED. TESTING ON THE ABBOTT I2000 SR SYSTEM YIELDED A NON-REACTIVE RESULT OF 0.21 COI, AND TESTING ON THE SIEMENS CENTAUR SYSTEM ALSO YIELDED A NON-REACTIVE RESULT OF 0.20 COI. AN EDTA SAMPLE DRAWN ON (B)(6) 2020 WAS TESTED USING THE COBAS HCV MONITORING TEST ON THE COBAS 6800 SYSTEM, WHICH ALSO REPORTED THE TARGET AS NOT DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074841 ↗
• MalfunctionSep 17, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ANTI-HCV RESULT WAS 9.27 COI, INTERPRETED AS POSITIVE. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS REPEATED ON TWO COMPETITOR ANALYZERS AND THE RESULTS FROM BOTH WERE NEGATIVE. THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED ON THE E 801 ANALYZER THE NEXT DAY AND THE RESULT WAS 9.27 COI. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073260 ↗
• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED A DISCREPANT POSITIVE RESULT FOR THE ANTI-HCV G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 MODULE WHEN COMPARED TO A NEGATIVE RESULT OBTAINED USING A BIOTIN-UPDATED VERSION OF THE ASSAY. THE DISCREPANCY WAS OBSERVED DURING A METHOD COMPARISON BETWEEN THE TWO ASSAY VERSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064779 ↗
• MalfunctionSep 16, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT ANTI-HCV G2 ELECSYS E2G 300 RESULTS BETWEEN THE COBAS E 801 ANALYTICAL UNIT AND THE COBAS E 601 ANALYZER DURING A VALIDATION STUDY. THE REPORTED RESULTS INCLUDED THE FOLLOWING: SAMPLE NO. (B)(6) SHOWED 39.54 COI ON THE COBAS E 601 AND 61.1/64 COI ON THE COBAS E 801. SAMPLE NO. (B)(6) SHOWED 21.35 COI ON THE COBAS E 601 AND 43.3/43.4 COI ON THE COBAS E 801. SAMPLE NO. (B)(6) SHOWED 22.78 COI ON THE COBAS E 601 AND 41.8/41.8 COI ON THE COBAS E 801.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062495 ↗
• MalfunctionAug 12, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PROFICIENCY SURVEY SAMPLE TESTED WITH ELECSYS ANTI-HCV II ON A COBAS E 801 MODULE. PROFICIENCY MATERIAL IS NOT USED FOR DIAGNOSTIC PURPOSES. THE EXPECTED ANTI-HCV RESULT FOR THE SAMPLE WAS NON-REACTIVE/NEGATIVE. WHEN THE CUSTOMER TESTED THE SAMPLE ON THE E 801 ANALYZER, THE RESULT WAS 1.27 COI (REACTIVE). THIS MEDWATCH IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786763 ↗
• MalfunctionNov 7, 2023Output Problem; Output Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023, THE INITIAL RESULT OF THE INITIAL SAMPLE FROM THE E 801 WAS"NON-REACTIVE" WITH A 0.0504 CUT-OFF INDEX (COI). THE PATIENT HAD A PREVIOUS REACTIVE RESULT ("HCV = 12.13", IN 2021) SO THEY SENT THE INITIAL PATIENT SAMPLE TO A SUPPORT LABORATORY THAT USES AN ABBOTT ANALYZER WITH CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAYS (CMIA) METHODOLOGY. ON (B)(6) 2023, THE FIRST REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM THE SUPPORT LABORATORY WAS "REACTIVE" WITH A 7.9 COI. ON (B)(6) 2023, THE SECOND REPEAT RESULT OF THE RECENTRIFUGED INITIAL PATIENT SAMPLE FROM THE E 801 WAS"NON-REACTIVE" WITH A 0.0481 COI. ON (B)(6) 2023, THE RESULT OF A NEW PATIENT SAMPLE FROM THE E 801 WAS "NON-REACTIVE" WITH A 0.06 COI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085058 ↗
• MalfunctionAug 19, 2022False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE VALUES FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS ANTI-HCV II. THE FIRST COMPLAINED SAMPLE (SAMPLE 3) WAS TESTED ON TWO COBAS 8000 E 801 MODULE ANALYZERS. THE SECOND COMPLAINED SAMPLE (SAMPLE 4) WAS TESTED ON AN UNKNOWN ROCHE ANALYZER. THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, A FIRST SAMPLE COLLECTED FROM THE PATIENT WAS TESTED USING THE ABBOTT ALINITY HEPATITIS C METHOD, RESULTING IN A VALUE OF 3.83 S/CO (REACTIVE). ON (B)(6) 2022, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS TESTED USING THE ABBOTT REAL TIME HCV VIRAL LOAD QUANTIFICATION METHOD, RESULTING IN A VALUE OF 5311136 IU/ML (6.72 LOG). ON (B)(6) 2022, A THIRD SAMPLE COLLECTED FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-HCV ON THE FIRST E 801 ANALYZER, RESULTING IN A VALUE OF 0.0439 COI (NON REACTIVE). THIS SAMPLE WAS REPEATED ON A SECOND E 801 ANALYZER ON (B)(6) 2022, RESULTING IN A NON-REACTIVE VALUE. ON (B)(6) 2022, A FOURTH SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2022 WAS TESTED ON AN UNKNOWN ROCHE ANALYZER ON (B)(6) 2022, RESULTING IN A VALUE OF 0.045 COI (NON REACTIVE). ON (B)(6) 2022, A FIFTH SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261657 ↗
• MalfunctionJul 11, 2022False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HCV II RESULTS FOR ONE PATIENT TESTED WITH A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S SAMPLE WAS TESTED ON THE E 801 MODULE ON (B)(6) 2022 AND ON (B)(6) 2022. THE ELECSYS ANTI-HCV RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2022 AND (B)(6) 2022, THE PATIENT'S SAMPLE WAS TESTED ON A MINI VIDAS BIOMERIEUX ANALYZER. ON (B)(6) 2022, THE PATIENT'S INITIAL ELECSYS ANTI-HCV RESULT WAS 0.0383 COI NON-REACTIVE. ON (B)(6) 2022, THE PATIENT'S INITIAL MINI VIDAS BIOMERIEUX ANTI-HCV RESULT WAS 2.38 COI REACTIVE. ON (B)(6) 2022, THE PATIENT'S FIRST REPEAT MINI VIDAS BIOMERIEUX ANTI-HCV RESULT WAS 4.42 COI REACTIVE. ON (B)(6) 2022, THE PATIENT'S SECOND REPEAT MINI VIDAS BIOMERIEUX ANTI-HCV RESULT WAS 4.28 COI REACTIVE. ON (B)(6) 2022, THE PATIENT'S REPEAT ELECSYS ANTI-HCV RESULT WAS 0.0384 COI NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14980279 ↗
• MalfunctionApr 8, 2022False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED A FALSE-NEGATIVE ELECSYS ANTI-HCV II IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). IT WAS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT FROM THE ANALYZER AT 10:36 WAS 0.0316 COI (NON-REACTIVE). THE RESULT FROM THE VIDAS ANALYZER WAS 6.9 (POSITIVE). THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE RESULT FROM THE BIORAD IMMUNOBLOT WAS NEGATIVE, WITH A NON-STRUCTURAL PROTEIN 3 (NS3) FINDING OF "DOUBT". THE RESULT FROM THE ARCHITECT WAS 11.43 (POSITIVE). THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051087 ↗
• MalfunctionDec 23, 2021False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED FALSE NEGATIVE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-HCV II IMMUNOASSAY ON TWO COBAS 8000 E 801 MODULE ANALYZERS. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER, RESULTING IN AN (B)(6) VALUE OF (B)(6). THE INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO A PHYSICIAN. THE SAMPLE WAS REPEATED USING THE ABBOTT METHOD, RESULTING IN A (B)(6) VALUE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED TWICE ON A SECOND E 801 ANALYZER, RESULTING IN (B)(6) VALUES OF (B)(6) AND (B)(6). THE SAMPLE WAS REPEATED WITH A CLEIA METHOD, RESULTING IN A VALUE OF (B)(6). THE SAMPLE WAS ALSO REPEATED USING THE (B)(6) METHOD ON (B)(6) 2021 AND (B)(6) 2021, RESULTING IN A (B)(6) VALUE ((B)(6) ANTIGEN REGIONS ARE ALL (B)(6)). THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE LOT NUMBER AND EXPIRATION DATE OF THE (B)(6) USED ON THIS ANALYZER WERE REQUESTED, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION WAS (B)(4). (B)(6) REAGENT LOT NUMBER 5676290, WITH AN EXPIRATION DATE OF 31-OCT-2022 WAS USED ON THIS ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079391 ↗
• MalfunctionSep 5, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF (B)(6) ELECSYS ANTI-HCV II IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 602 MODULE AND A COBAS 8000 E 801 MODULE. THE E 602 MODULE SERIAL NUMBER WAS (B)(6) AND THE E 801 MODULE SERIAL NUMBER WAS (B)(6). THE INITIAL ANTI-HCV II RESULT WAS (B)(6) ON THE E 602 MODULE WITH REAGENT LOT NUMBER 31063600. THE PATIENT QUESTIONED THE RESULT. ON (B)(6) 2018, THE REPEAT ANTI-HCV II RESULT WAS (B)(6) ON THE E 801 MODULE WITH REAGENT LOT NUMBER 31072500. THE CUSTOMER THEN SENT THE SAMPLE TO A DIFFERENT LABORATORY AND THE ANTI-HCV RESULT WAS (B)(6) WITH THE IMMUNOBLOT METHOD. THE SPECIFIC DATE OF THE IMMUNOBLOT RESULT WAS NOT PROVIDED. THERE WERE ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THIS MEDWATCH WILL COVER ANTI-HCV II REAGENT LOT NUMBER 31063600. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON ANTI-HCV II REAGENT LOT NUMBER 31072500.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7845478 ↗