Elecsys CA 19-9 07027028190Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04015630939640), received between Nov 27, 2019 and Mar 5, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “High Test Results” (27 reports).

1 other recall cover devices cleared under the same FDA submission (K050231); they may or may not involve this specific model.

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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026False Positive Result; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS 8000 CORE UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 52.7 U/ML, AND THE REPEAT RESULT WAS <2 U/ML. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY, AS THE CUSTOMER NOTICED THAT THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND REPEATED THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520823 ↗
• MalfunctionJan 16, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 46.1 U/ML. THE SAMPLE WAS REPEATED TWICE, AND THE RESULTS WERE BOTH 2.00 U/ML WITH A DATA FLAG. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094698 ↗
• MalfunctionDec 22, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT IS 69.1 U/ML. THE REPEATED RESULT IS 3.99 U/ML (REPORTED AS 4.0 U/ML). THIS RESULT WAS CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865979 ↗
• MalfunctionDec 3, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. AN INTERFERENCE WAS SUSPECTED. ON (B)(6) 2025, THE PATIENT UNDERWENT A PHYSICAL EXAMINATION, AND THE CA-199 RESULT WAS 97.2 U/ML. THE PATIENT UNDERWENT ENHANCED CT SCANS AND GASTROSCOPY/COLONOSCOPY, BOTH OF WHICH REVEALED NO ABNORMALITIES. AN EXCLUSION EXPERIMENT WAS CONDUCTED ON THE SAMPLE FROM (B)(6) 2025: 1) CA19-9 ORIGINAL DILUTION: 97.2 U/ML. 2) 1:2 DILUTION RESULT: 69.6 U/ML. 3) 1:5 DILUTION RESULT: 90 U/ML. 4)PEG6000 SEDIMENTATION TEST: RESULTS OF PEG6000 SEDIMENTATION IN PATIENT SAMPLES AT A 1:1 RATIO: 2U/ML WITH A DATA FLAG. AFTER SETTLING, THE RESULTS DECREASED TO NORMAL, INDICATING SIGNIFICANT DISTURBANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703766 ↗
• MalfunctionNov 19, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <10000 U/ML. THE REPEAT RESULTS WERE <10000 AND 46.3 U/ML WITH DILUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594546 ↗
• MalfunctionAug 14, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 19-9 (CA 19-9) ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM THE E801 ANALYZER WAS 101 U/ML. THE REPEAT WAS 100 U/ML. THE SAMPLE WAS REPEATED BY AN UNSPECIFIED COMPETITOR METHOD, AND THE RESULT WAS 11.0 U/ML. THE RESULT OF 11.0 U/ML WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806063 ↗
• MalfunctionJun 11, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CARBOHYDRATE ANTIGEN 19-9 (CA 19-9) ASSAY ON A COBAS E801 ANALYTICAL UNIT. INITIAL RESULT: 51.1 U/ML. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, AND THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 11.8 U/ML. 2ND REPEAT RESULT: 11.6 U/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183076 ↗
• MalfunctionOct 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CA 19-9 ASSAY ON A COBAS E801 MODULE. INITIAL RESULT: >1000 U/ML. REPEAT RESULT: 133 U/ML (TESTED WITH AN AUTOMATIC 10 TIMES DILUTION). THE SAMPLE OBTAINED AN ADDITIONAL REPEAT VALUE OF >1000 U/ML. REPEAT RESULT: 155 U/ML (TESTED WITH AN AUTOMATIC 10 TIMES DILUTION). THE ORIGINAL SAMPLE WAS THEN MANUALLY DILUTED WITH NORMAL SALINE AND OBTAINED THE FOLLOWING REPEAT RESULTS: 73.3 U/ML (TESTED WITH 5 TIMES DILUTION). 13.2 U/ML (TESTED WITH 10 TIMES DILUTION). 3.2 U/ML (TESTED WITH 20 TIMES DILUTION). SINCE THE RESULT DECREASED GRADUALLY WITH THE INCREASE OF THE DILUTION RATIO, THE CUSTOMER SUSPECTED AN INTERFERENCE. THE ORIGINAL SAMPLE WAS ALSO TREATED WITH POLYETHYLENE GLYCOL (PEG) TREATMENT AND THE RESULT WAS 17.88 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452866 ↗
• MalfunctionSep 24, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 ASSAY RESULTS FROM ONE SAMPLE FROM THE SAMPLE PATIENT TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER STATED THAT THE PATIENT'S RESULTS FROM (B)(6) 2024 WERE CONSISTENTLY <10 U/ML. THEY NOTICED THE RESULTS STARTED TO INCREASE IN (B)(6) 2024. ON (B)(6) 2024, THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 80.5 U/ML. ON (B)(6) 2024, THE REPEAT RESULT WAS 88.4 U/ML. THE PATIENT THEN WENT TO ANOTHER LABORATORY THAT USES A BECKMAN ANALYZER. THE RESULT OF THE PATIENT SAMPLE IN THIS LABORATORY WAS 4.0 IU/ML. THE INITIAL PATIENT SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY FOR VERIFICATION: ON (B)(6) 2024: THE REPEAT RESULT FROM THE DIASORIN ANALYZER WITH CHEMILUMINESCENCE AS THE LABORATORY METHOD WAS 7 U/ML. THE REPEAT RESULT FROM THE VIDAS ANALYZER THAT USES THE ENZYME-LINKED FLUORESCENT ASSAY (ELFA) LABORATORY METHOD WAS 7 U/ML. THE REPORTER COMPLAINED THAT ALL THE COMPETITOR RESULTS WERE IN THE NORMAL RANGE AND ONLY THE RESULTS FROM THE ANALYZER WERE PATHOLOGICAL AND INCREASING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292974 ↗
• MalfunctionSep 13, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS CA 19-9 ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 723 U/ML. THE PATIENT QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH A RESULT THAT WAS OBTAINED AT A DIFFERENT LABORATORY. ON (B)(6) 2024 THE SAMPLE WAS THEN REPEATED AND THE REPEAT RESULT WAS 11.8 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214518 ↗
• MalfunctionJun 13, 2024Low Test Results; Manufacturing, Packaging or Shipping Problem; Non Reproducible Results; Low Test Results; Manufacturing, Packaging or Shipping Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <2 U/ML ON (B)(6) 2024, THE REPEAT RESULTS WERE 126 U/ML AND 125 U/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527158 ↗
• MalfunctionJun 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 45.4 U/ML. THE REPEAT RESULT WAS 4.18 U/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483553 ↗
• MalfunctionApr 17, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 788 U/ML. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2024 A NEW SAMPLE WAS TESTED AND THE RESULT WAS 14.80 U/ML. CONSIDERING THAT THE CA 19-9 RESULTS DECREASED SIGNIFICANTLY OVER A 5-DAY PERIOD, AND THAT THE PATIENT'S TESTS DURING THE HOSPITAL STAY FOUND NO OTHER ABNORMALITIES, THE DOCTORS QUESTIONED THE RESULTS FROM (B)(6) 2024. THE SAMPLE FROM (B)(6) 2024 WAS RETESTED AND THE RESULTS WERE 15.90 U/ML AND 16.20 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125791 ↗
• MalfunctionMar 8, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CA 19-9 ON A COBAS PURE E 402 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 144 U/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A CA 19-9 VALUE OF 8.94 U/ML. THE SAMPLE WAS ALSO REPEATED THREE TIMES ON A SECOND COBAS INSTRUMENT IN THE LABORATORY ON (B)(6) 2024, RESULTING IN CA 19-9 VALUES OF 9.14 U/ML, 9.25 U/ML, AND 9.16 U/ML. THE SAMPLE WAS ALSO REPEATED ON A COMPETITOR INSTRUMENT AND THE LOWER VALUE WAS CONFIRMED. NO SPECIFIC DATA WAS PROVIDED FROM THIS INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864798 ↗
• MalfunctionFeb 16, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CA 19-9 ON A COBAS E 801 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 59.6 U/ML. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A CA 19-9 VALUE OF 6.29 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720802 ↗
• MalfunctionDec 11, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 19-9 (CA 19-9) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 72.6 U/ML. THE REPEAT RESULT WAS 5.86 U/ML. THE SAMPLE WAS REPEATED ON A DIFFERENT "MACHINE" AND THE RESULT WAS 5.83 U/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302559 ↗
• MalfunctionSep 5, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH ELECSYS CA 19-9 ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. ON (B)(6) 2023: INITIAL RESULT: 466 U/ML. 1ST REPEAT RESULT: 462 U/ML. 2ND REPEAT RESULT: 405 U/ML. THE PHYSICIAN QUESTIONED THE RESULTS FROM THIS SAMPLE AS THEY DID NOT MATCH THE PATIENT¿S CLINICAL PICTURE. THE RESULTS THAT ARE BELOW 100 U/ML WERE DEEMED TO BE CORRECT AND ACCEPTED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683822 ↗
• MalfunctionJul 21, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT SAMPLE WAS TESTED TWICE AND GAVE AN UNDILUTED CA 19-9 RESULT OF 1500 U/ML AND 10 FOLD DILUTION RESULT OF 1500 U/ML. A SECOND PATIENT SAMPLE WAS COLLECTED THE SAME DAY. THE SECOND PATIENT SAMPLE WAS TESTED TWICE AGAIN AND GAVE AN UNDILUTED CA 19-9 RESULT OF 340 U/ML AND 10 FOLD DILUTION RESULT OF 340 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373469 ↗
• MalfunctionFeb 6, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306775 ↗
• MalfunctionOct 4, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CA 19-9 IMMUNOASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 35.0 U/ML WITH A FLAG AND REPEATED AS 399 U/ML WITH A FLAG. THE 399 U/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE RESULT WAS QUESTIONED AND THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2022, RESULTING IN VALUES OF 37.3 U/ML WITH A FLAG AND 36.5 U/ML WITH A FLAG. A CORRECTED REPORT WAS ISSUED. AN ADDITIONAL REPEAT VALUE OF 37.6 U/ML FROM (B)(6) 2022 WAS ALSO PROVIDED, BUT IT IS UNKNOWN IF THIS VALUE WAS PROVIDED IN ERROR OR IF IT REPRESENTS AN ADDITIONAL REPEAT VALUE FROM THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537962 ↗
• MalfunctionMar 9, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CA 19-9 ELECSYS E2G RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. IT WAS REQUESTED BUT NOT PROVIDED IF THE INITIAL CA 19-9 RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED DILUTION TESTING WITH THE PATIENT'S SAMPLE DUE TO THE INITIAL CA 19-9 RESULT NOT MATCHING THE PATIENT'S PREVIOUS RESULT. THE PATIENT'S INITIAL UNDILUTED CA 19-9 RESULT WAS 431 U/ML. THE PATIENT'S REPEAT CA 19-9 RESULT WITH A 1:2 DILUTION WAS 569 U/ML. THE PATIENT'S REPEAT CA 19-9 RESULT WITH A 1:10 DILUTION WAS 905 U/ML. THE E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712724 ↗
• MalfunctionMar 8, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CA 19-9 ELECSYS E2G (CA 19-9) ON A COBAS E801 MODULE. THE INITIAL RESULT WAS 113 U/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022 THE SAMPLE WAS REPEATED WITH A RESULT OF 9.91 U/ML. ON (B)(6) 2022 THE SAMPLE WAS REPEATED WITH A RESULT OF 8.99 U/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND WERE PROVIDED TO THE DOCTOR. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693018 ↗
• MalfunctionMar 3, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT'S SAMPLE WAS RERUN TWICE BECAUSE THE INITIAL RESULT DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE INITIAL RESULT AT 10:16 WAS 56.2 U/ML. THE FIRST REPEAT RESULT AT 10:16 WAS <2.00 WITH A DATA FLAG. THE SECOND REPEAT RESULT 11:47 WAS <2.00 WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660732 ↗
• MalfunctionJan 10, 2022Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 9 PATIENT SAMPLES TESTED WITH THE ELECSYS CA 19-9 IMMUNOASSAY. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. FOR THE FIRST FIVE PATIENT SAMPLES, THE RESULTS MEASURED AFTER AUTOMATIC DILUTION DID NOT AGREE WHEN TESTED ON THE COBAS 8000 E 801 MODULE. FOR SAMPLES 6 THROUGH 9, THE CA 19-9 RESULTS MEASURED ON THE E 801 ANALYZER DID NOT AGREE WITH MEASUREMENTS PERFORMED ON THE COBAS 8000 E 602 MODULE. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4). THE SERIAL NUMBER OF THE E 602 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205704 ↗
• MalfunctionJan 7, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CA 19-9 IMMUNOASSAY ON A COBAS 8000 E 801 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 31 U/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 19 U/ML. THE SAMPLE WAS ALSO REPEATED ON THE ORIGINAL E 801 ANALYZER, RESULTING IN A VALUE OF 19 U/ML. THE SERIAL NUMBER OF THE E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190210 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050231. One submission often covers many models, so check the product and lot details in each record.

• Z-1444-2020 · Feb 7, 2020 · Terminated
  Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer