Elecsys CA 199 Immunoassay 11776193122Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04015630904297), received between Jul 16, 2018 and Jan 30, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (20 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.

• MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 74.01 U/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT 18.16 U/ML. THE SECOND REPEAT RESULT 1.86 U/ML. THE THIRD REPEAT RESULT 1.61 U/ML. THE INITIAL AND FIRST REPEAT RESULTS WERE QUESTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221768 ↗
• MalfunctionJan 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 579 U/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 8.65 U/ML AND 8.75 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162207 ↗
• MalfunctionJan 16, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT ON A COBAS E 602 MODULE. AN INTERFERENCE WITH THE ELECSYS CA 19-9 ASSAY WAS SUSPECTED. ON (B)(6) 2025, THE PATIENT'S RESULT WAS 793.5 U/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 836.6 U/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS >1000 U/ML. A DILUTION (1:10) WAS PERFORMED, AND THE RESULT WAS 1370 U/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS >1000 U/ML. A DILUTION (1:10) WAS PERFORMED, AND THE RESULT WAS 1064 U/ML. THE RESULTS WERE INCONSISTENT WITH THE PATIENT'S CLINICAL DIAGNOSIS (NOT PROVIDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094700 ↗
• MalfunctionJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM) FOR ONE PATIENT. THE INITIAL RESULT WAS 1000 U/ML, ACCOMPANIED BY A DATA FLAG. THE SECOND RESULT WITH A DILUTION OF 1:10 WAS 172 U/ML. THE THIRD RESULT WAS 331.4 U/ML. THE RESULT ON ANOTHER E411 WAS 1000 U/ML, ACCOMPANIED BY A DATA FLAG. A NEW SAMPLE WAS COLLECTED ON THE SAME DAY, AND THE INITIAL RESULT WAS 29.71 U/ML. THE RESULTS FROM THE OTHER E411 WERE 27.22 U/ML AND 32.65 U/ML, WHICH WERE DEEMED TO BE CORRECT. ON (B)(6) 2025, THE SAMPLE WAS SENT TO ANOTHER LAB. THE RESULT ON AN E 411 WAS 219.7 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038449 ↗
• MalfunctionAug 13, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. THE INITIAL CA 19-9 RESULT FROM A 1:10 DILUTED SAMPLE WAS 12.12 U/ML. THE CUSTOMER QUESTIONED THE LOW RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND REPEATED THE SAMPLE. THE REPEAT RESULT FROM A 1:10 DILUTED SAMPLE WAS 9502 U/ML. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792403 ↗
• MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 602 MODULE AND COBAS E 801 ANALYZER ON (B)(6) 2025: THE INITIAL RESULT FROM THE E 602 MODULE IS 120 U/ML. THE REPEAT RESULT FROM THE E 602 MODULE WITH THE PATIENT SAMPLE AT 1:5 DILUTION WAS 126.3 U/ML. THE REPEAT RESULT FROM THE E 602 MODULE WITH THE PATIENT SAMPLE AT 1:10 DILUTION WAS 127.8 U/ML. THE REPEAT RESULT FROM THE E 801 ANALYZER WAS 75.1 U/ML. THE REPORTER SUSPECTED AN INTERFERENT IN THE PATIENT SAMPLE AND PERFORMED A POLYETHYLENE GLYCOL (PEG) TREATMENT TEST. ON (B)(6) 2025: THE RESULT OF THE PEG TEST FROM THE E 602 MODULE WAS 1.40 U/ML, WITH A RECOVERY RATE OF 40%. THE REPORTER STATED THAT THIS RESULT CONFIRMED AN INTERFERENT IN THE PATIENT SAMPLE. THE RESULT OF THE PARALLEL TEST FROM THE MODULE WAS 121.0 U/ML. THE REPEAT RESULT FROM A COMPETITOR ANALYZER WAS 5.19 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574511 ↗
• MalfunctionJun 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 7.4 IU/ML. THE PATIENT WAS RETESTED AT ANOTHER LAB WITH A RESULT OF 940 IU/ML. THE INITIAL SAMPLE WAS RETESTED, AND THE REPEAT RESULT WAS 710 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176056 ↗
• MalfunctionMay 30, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT ON (B)(6) 2025 WAS <0.6 U/ML, AND THE REPEAT RESULT WAS 49.54 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116019 ↗
• MalfunctionMay 5, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 132.6 U/ML AND THE REPEAT RESULT WAS 80.09 U/ML. ANOTHER SAMPLE TAKEN FROM THE SAME PATIENT AT THE SAME TIME HAD A RESULT OF 6.91 U/ML, AND THIS RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960198 ↗
• MalfunctionApr 22, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 55.53 U/ML. THE REPEAT RESULTS WERE 0.979 U/ML AND 1.61 U/ML. ADDITIONAL RESULTS OF 0.200 NG/ML WITH A DATA FLAG AND 1.97 NG/ML WERE PROVIDED FROM THE DATE OF (B)(6) 2025. IT WAS UNCLEAR IF THESE RESULTS WERE ADDITIONAL REPEAT TESTS OF THE SAMPLE. CLARIFICATION WAS REQUESTED BUT HAS NOT YET BEEN PROVIDED. THE RESULT OF 0.979 U/ML WAS RELEASED DUE TO THE PATIENT'S CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881672 ↗
• MalfunctionMar 5, 2025High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS 6000 E601 MODULE. ON (B)(6) 2025 THE INITIAL RESULT WAS 42.92 U/ML, AND THE REPEAT RESULT WAS 17.84 U/ML. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LAB AND THE REPEAT RESULT WAS DEEMED TO BE CORRECT. ON (B)(6) 2025 THE INITIAL RESULT WAS 162.4 U/ML, AND THE REPEAT RESULTS WERE 17.05 U/ML, 11.73 U/ML, AND 12.4 U/ML. ON (B)(6) 2025 THE INITIAL RESULT WAS 28.45 U/ML, AND THE REPEAT RESULTS WITH A DIFFERENT REAGENT PACK WERE 6.45 U/ML, 6.27 U/ML, AND 6.27 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526381 ↗
• MalfunctionDec 4, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 AND ELECSYS CEA RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CA 19-9 ASSAY. PLEASE REFER TO MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CEA ASSAY. ON (B)(6) 2024: THE INITIAL RESULT FROM THE REPORTED REAGENT LOT WAS 459.90 U/ML. THE FIRST REPEAT RESULT FROM A DIFFERENT ELECSYS CA19-9 REAGENT PRODUCT WAS 28.82 U/ML. ON (B)(6) 2024: THE SECOND REPEAT RESULT FROM A NEW REAGENT PACK OF THE SAME REPORTED REAGENT LOT WAS 26.52 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846874 ↗
• MalfunctionNov 26, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 506.6 U/ML. THE REPEAT RESULTS WERE 9.49 U/ML, 9.42 U/ML, AND 9.52 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785569 ↗
• MalfunctionSep 13, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL CA 19-9 RESULT WAS 257.9 U/ML. THE REPORTER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 11.98 U/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212778 ↗
• MalfunctionApr 16, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A SUSPECTED INTERFERENCE WITH THE ELECSYS CA 19-9 ASSAY ON A COBAS 8000 E 602 MODULE. IN 2020, THE PATIENT'S RESULT WAS 16.11 U/ML. THE SPECIFIC DATE WAS NOT PROVIDED. ON (B)(6) 2024, THE PATIENT'S RESULT WAS 365.4 U/ML AND THE REPEATED RESULT WAS 360.9 U/ML ON THE E 602 MODULE. ON (B)(6) 2024, THE PATIENT'S RESULT WAS 14.33 U/ML WITH ANOTHER METHOD (MINDRAY CL6000I) . ON (B)(6) 2024, THE PATIENT'S SAMPLE FROM (B)(6) 2024 WAS RETESTED ON THE E602 MODULE AND THE RESULTS WERE 334.9 U/ML AND 358.2 U/ML. ON (B)(6) 2024, THE PATIENT'S RESULT WAS 14 U/ML WITH ANOTHER METHOD (SNIBE MAGLUMI X8). THIS SAMPLE WAS ALSO SENT TO BE TESTED ON OTHER INSTRUMENTS AND THE RESULTS WERE: THE RESULT USING A COBAS E801 MODULE WAS 364 U/ML. THE RESULT USING ABBOTT ALINITY WAS >1200 U/ML. THE RESULT USING BECKMAN DXI800 WAS 10.8 U/ML. THE RESULT USING WANTAI WAS 14.93 U/ML. ON (B)(6) 2024, THE PATIENT'S RESULT WAS 308.9 U/ML ON THE E 602 MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19120040 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM SIX SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 8000 - COBAS E 602 MODULE. THE REPORTER STATED THAT THE PATIENT HAS BEEN REGULARLY TESTED FOR THE ASSAY OVER THE PAST 3 YEARS ON THE ANALYZER. THE RESULTS WERE ALWAYS HIGH BUT NO TUMOR WAS FOUND DURING THE EXAMINATIONS. THE PATIENT'S SAMPLE WAS RECENTLY TESTED IN A DIFFERENT INSTITUTION THAT USES A BECKMAN COULTER DXI 800; THE RESULT WAS WITHIN THE NORMAL RANGE. ON (B)(6) 2021, THE RESULT FROM THE MODULE WAS >1000 U/ML. ON (B)(6) 2022, THE RESULT FROM THE MODULE WAS >1000 U/ML. ON (B)(6) 2023, THE RESULT FROM THE MODULE WAS 723.20 U/ML. ON (B)(6) 2023, THE RESULT FROM THE MODULE WAS 781.7 U/ML. ON (B)(6) 2024, THE RESULT FROM THE MODULE WAS 540.9 U/ML. ON (B)(6) 2024, THE RESULT FROM THE MODULE WAS 457.5 U/ML. THE REPEAT RESULT FROM ANOTHER E602 MODULE WAS 478.7 KU/L. ON (B)(6) 2024, THE RESULT FROM THE BECKMAN COULTER DXI 800 ANALYZER WAS 13 U/ML (<35).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697630 ↗
• MalfunctionJan 30, 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 6000 CORE UNIT. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 55.5 U/ML AND IT REPEATED AS 1.2 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609028 ↗
• MalfunctionJan 29, 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 CA 19-9 ELECSYS RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE THAT WERE QUESTIONED BY THE CLINICIANS. ON (B)(6) 2023, SAMPLE 1 INITIAL RESULT WAS >1000 KU/L AND THE RESULT ON (B)(6) 2023 WITH A 1:10 DILUTION WAS 400.3 KU/L. ON (B)(6) 2023, SAMPLE 2 INITIAL RESULT WAS >1000 KU/L AND THE RESULT WITH A 1:10 DILUTION WAS 196.6 KU/L. SAMPLE 3 INITIAL RESULT WAS >1000 KU/L AND THE RESULT WITH DILUTION WAS 465.0 KU/L. SAMPLE 4 INITIAL RESULT WAS >1000 KU/L AND THE RESULT WITH A 1:10 DILUTION WAS 103.0 KU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596608 ↗
• MalfunctionNov 14, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CA 19-9 ELECSYS RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS 2.77 U/ML. THE FIRST REPEAT RESULT WAS 51.01 U/ML. THE SECOND REPEAT RESULT WAS 3.00 U/ML. THE REPORTER STATED THAT THEY EXPECTED THE LOWER RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130974 ↗
• MalfunctionOct 10, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA 19-9 ELECSYS RESULTS FROM THE COBAS 6000 E601 MODULE. SAMPLE 1 INITIAL RESULT WAS 49.85 U/ML. THE REPEAT RESULTS WERE 64.55 U/ML AND 64.58 U/ML. ON (B)(6) 2023 SAMPLE 2 INITIAL RESULT WAS 28.79 U/ML. THE REPEAT RESULTS WERE 36.99 U/ML AND 35.93 U/ML. THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903586 ↗
• MalfunctionFeb 22, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CA 19-9 ASSAY ON COBAS 6000 E 601 MODULES. THE SAMPLE WAS INITIALLY TESTED ON E 601, SERIAL NUMBER: (B)(4), RESULTING IN AN ALARM MESSAGE. THE SAMPLE WAS REPEATED ON A SECOND E 601 (SERIAL NUMBER: (B)(4) RESULTING IN A CA 19-9 VALUE OF 1000 U/ML, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:10 DILUTION ON THE SAME ANALYZER, RESULTING IN A VALUE OF 52.74 U/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN REPEATED TWICE ON THE INITIAL ANALYZER, RESULTING IN CA 19-9 VALUES OF 1000 U/ML, ACCOMPANIED BY A DATA FLAG AND 9019 U/ML USING A 1:10 DILUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419419 ↗
• MalfunctionJan 18, 2023High 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 6000 E 601 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 43.72 IU/ML AND REPEATED AS < 0.600 IU/ML WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A SAMPLE CUP AND REPEATED, RESULTING IN A CA 19-9 VALUE OF < 0.600 IU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED AGAIN, RESULTING IN A VALUE OF < 0.600 IU/ML WITH A DATA FLAG. A NEW CA 19-9 REAGENT LOT WAS PLACED ON BOARD AND THE SAMPLE WAS REPEATED TWO MORE TIMES ON (B)(6) 2023, RESULTING IN CA 19-9 VALUES OF < 0.600 IU/ML WITH A DATA FLAG AND 0.693 IU/ML. THE CA 19-9 REAGENT LOT NUMBER WAS 59810303, WITH AN EXPIRATION DATE OF 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193628 ↗
• MalfunctionDec 5, 2022Low Test Results; Non Reproducible Results; Low 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 6000 E 601 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF < 0.600 U/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED IN THE SAME TUBE, RESULTING IN A VALUE OF 65.27 U/ML ON (B)(6) 2022. THE SAMPLE WAS THEN POURED INTO A CUP AND REPEATED, RESULTING IN A VALUE OF 64.74 U/ML ON (B)(6) 2022. THE CA 19-9 REAGENT LOT NUMBER WAS 59810303, WITH AN EXPIRATION DATE OF 31-AUG-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915120 ↗
• MalfunctionNov 21, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL CA 19-9 RESULT WAS > 1000 U/ML. A 1:5 DILUTION WAS MADE WITH THE PATIENT SAMPLE AND THE RESULT WAS 242.2 U/ML. THE SAMPLE WAS RUN UNDILUTED AGAIN AND THE RESULT WAS > 1000 U/ML. A 1:2 DILUTION WAS THEN MADE WITH THE PATIENT SAMPLE AND THE RESULT WAS 481.4 U/ML. THE SAMPLE WAS RECENTRIFUGED AND RUN UNDILUTED AGAIN AND THE RESULT WAS > 1000 U/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER IS 598103. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15836483 ↗
• MalfunctionOct 20, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CA 19-9 ELECSYS RESULT FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 40.32 U/ML WHICH WAS CONSIDERED WRONG AND NOT RELEASED TO THE PATIENT OR DOCTOR. THE REPEAT RESULT FROM ANOTHER COBAS E601 ANALYZER WAS 9.89 U/ML. THE REPEAT RESULT ON THE SAME ANALYZER WAS 9.12 U/ML WITH A DATA FLAG AND THEN 9.13 U/ML. THIS RESULT WAS CONSIDERED CORRECT AND RELEASED TO THE PATIENT. THE REAGENT LOT NUMBER WAS 598103 WITH AN EXPIRATION DATE OF 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15637720 ↗

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