Elecsys Estradiol III 6656021190Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 04015630933358), received between Jul 27, 2018 and Aug 14, 2026 — classified as 101 malfunctions.

The most frequently reported specific device problem is “High Test Results” (70 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026High Test Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50259956 ↗
• MalfunctionApr 16, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 36.64 PG/ML. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 15.71 PG/ML. THE REPEATED RESULT WAS DEEMED CORRECT AS IT COINCIDED WITH THE PATIENT'S MENSTRUAL CYCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897164 ↗
• MalfunctionFeb 3, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS <5 PG/ML. THE REPEATED RESULT WAS 32.28 PG/ML. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE NURSE DIDN'T BELIEVE THE INITIAL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247736 ↗
• MalfunctionJan 13, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ESTRADIOL III ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). INITIAL RESULT: 3000 PG/ML (ACCOMPANIED BY A DATA FLAG). THE DATA FLAG ACCOMPANYING THE INITIAL RESULT PROMPTED THE REPEAT OF THE SAMPLE USING A DILUTION FACTOR OF 1:10 TWICE. 1ST REPEAT RESULT: 1904 PG/ML. 2ND REPEAT RESULT: 1731 PG/ML. IT WAS NOTED THAT THE 2ND REPEAT RESULT OF 1731 PG/ML WAS CONSIDERED TO BE THE MOST ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057909 ↗
• MalfunctionDec 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FROM THE COBAS E411 RACK. THE INITIAL RESULT WAS >3000 PG/ML WITH A DATA FLAG. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN, AS THE ESTRADIOL RESULT FOR THE PATIENT ON THE PREVIOUS DAY WAS 2800 PG/ML. WITH A DILUTION, THE REPEAT RESULTS WERE 2100 PG/ML, 2300 PG/ML, AND 2500 PG/ML. THE SAMPLE WAS THEN SENT TO ANOTHER LABORATORY, AND THE RESULT WAS 2900 NG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876426 ↗
• MalfunctionDec 16, 2025High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 32.7 PG/ML, AND THE REPEATED RESULT WAS 1432 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821465 ↗
• MalfunctionDec 15, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 22.52 PG/ML. THE REPEATED RESULT WAS 63.23 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER CLEANED THE LIQUID FLOW PATH AND REPEATED THE SAMPLE. THE RESULT WAS 19.20 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805953 ↗
• MalfunctionNov 25, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT 1: THE INITIAL RESULT WAS 1438 PMOL/L. THE REPEATED RESULTS WERE 1864 PMOL/L, 2111 PMOL/L, AND 1625 PMOL/L. PATIENT 2: THE INITIAL RESULT WAS 791.7 PMOL/L. THE REPEATED RESULTS WERE 1259 PMOL/L, 853.2 PMOL/L, AND 821.3 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644694 ↗
• MalfunctionNov 21, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 59 PG/ML. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 57.9 PG/ML. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 5 PG/ML. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULTS WERE INCONSISTENT WITH THE PATIENT'S CLINICAL SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619059 ↗
• MalfunctionNov 20, 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 ESTRADIOL III ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 560 NG/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS THEN REPEATED ON (B)(6) 2025, AND THE REPEAT RESULT WAS 86.94 NG/L. THE REPEAT RESULT WAS ACCEPTED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602924 ↗
• MalfunctionOct 27, 2025Incorrect Measurement; High Test Results; Low Test Results; Incorrect Measurement; High Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FROM FIFTEEN PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS FOR THREE PATIENT SAMPLES WERE PROVIDED: PATIENT SAMPLE 1. THE INITIAL RESULT IS >3000 PG/ML. THE FIRST REPEAT RESULT AT 1:10 DILUTION IS 1205 PG/ML. THE SECOND REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE IS 2916 PG/ML. THE THIRD REPEAT RESULT AT 1:10 DILUTION IS 1279 PG/ML. THE FOURTH REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM A NEW REAGENT PACK WITH IMPROVED CALIBRATION AND QC IS 1601 PG/ML. THIS RESULT WAS DEEMED CORRECT BY THE NURSING STAFF. PATIENT SAMPLE 2. THE INITIAL RESULT IS >3000 PG/ML. THE FIRST REPEAT RESULT AT 1:10 DILUTION IS 1805 PG/ML. THE SECOND REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE IS >3000 PG/ML. THE THIRD REPEAT RESULT AT 1:10 DILUTION IS 1773 PG/ML. THE FOURTH REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM A NEW REAGENT PACK WITH IMPROVED CALIBRATION AND QC IS 2524 PG/ML. THIS RESULT WAS DEEMED CORRECT BY THE NURSING STAFF. THE FIFTH REPEAT RESULT AT 1:10 DILUTION IS 1717 PG/ML. PATIENT SAMPLE 3. THE INITIAL RESULT IS >3000 PG/ML. THE FIRS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393331 ↗
• MalfunctionOct 20, 2025Output Problem; Output Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT SAMPLE 1 THE INITIAL RESULT WAS >3000 PG/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 1884 PG/ML. PATIENT SAMPLE 2 THE INITIAL RESULT WAS >3000 PG/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 2031 PG/ML. PATIENT SAMPLE 3 THE INITIAL RESULT WAS >3000 PG/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 2505 PG/ML. PATIENT SAMPLE 4 THE INITIAL RESULT WAS >3000 PG/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 2506 PG/ML. PATIENT SAMPLE 5 THE INITIAL RESULT WAS >3000 PG/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 2245 PG/ML. PATIENT SAMPLE 6 THE INITIAL RESULT WAS >3000 PG/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 1717 PG/ML. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY, AS MULTIPLE PATIENT SAMPLE RESULTS OF >3000 PG/ML, PROMPTING THE RERUN. THE REPEAT RESULTS WERE DEEMED CORRECT, AS THEY MATCHED THE RESULTS FROM ANOTHER LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337480 ↗
• MalfunctionOct 15, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS >3000 PG/ML WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED, AND THE RESULT WAS 1242 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. DUE TO THE DISCREPANCY, THE SAMPLE WAS RETESTED WITHOUT DILUTION, AND THE RESULT WAS 1140 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302979 ↗
• MalfunctionSep 12, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH THE ELECSYS ESTRADIOL III ASSAY ON A COBAS 6000 E 601 ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF > 3000 PG/ML WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DILUTION, RESULTING IN A VALUE OF 2249 PG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF > 3000 PG/ML WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DILUTION, RESULTING IN A VALUE OF 2360 PG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF > 3000 PG/ML WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DILUTION, RESULTING IN A VALUE OF 2397 PG/ML. THE FOURTH SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF > 3000 PG/ML WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DILUTION, RESULTING IN A VALUE OF 2601 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042566 ↗
• MalfunctionSep 12, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS >3000 PG/ML WITH A DATA FLAG. THE REPEAT RESULT WITH A 1:10 DILUTION WAS 2322 PG/ML. THE SAMPLE WAS REPEATED WITHOUT A DILUTION, AND THE RESULT WAS >3000 PG/ML WITH A DATA FLAG. THE REPEAT RESULT WITH A 1:10 DILUTION WAS 2268 PG/ML. THE RESULT WITH A MANUAL 1:10 DILUTION THAT WAS TESTED ON THE INSTRUMENT WITH NO AUTODILUTION WAS 2884 PG/ML. THE RESULT WITH A 1:2 DILUTION WAS 2634 PG/ML. THE RESULT WITH A 1:5 DILUTION WAS 2614 PG/ML. THE RESULT OF 2884 PG/ML WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036513 ↗
• MalfunctionSep 10, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ESTRADIOL III ASSAY ON A COBAS E411 RACK. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE RESULTED IN AN ESTRADIOL VALUE OF > 10000. A DOCTOR QUESTIONED THE RESULT BECAUSE IT DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS. A PREVIOUS SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2025 RESULTED IN AN ESTRADIOL VALUE OF 300.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017970 ↗
• MalfunctionAug 29, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION REGARDING DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ESTRADIOL III ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 2192 PG/ML (REPEATED AUTOMATICALLY BY THE ANALYZER WITH A DILUTION OF 1:10). 2ND REPEAT RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 3RD REPEAT RESULT: 2240 PG/ML (TESTED WITH A DILUTION OF 1:10). THE 3RD REPEAT RESULT WAS DEEMED CORRECT AND REPORTED OUTSIDE THE LABORATORY. THE ANALYZER'S AUTO-RERUN AND ISSUES WITH DILUTION PROMPTED THE RERUNS OF THE PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920578 ↗
• MalfunctionAug 20, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS E 411 ANALYZER. THE INITIAL ESTRADIOL RESULT WAS >3000 PG/ML WITH FLAG. A 1:10 DILUTION WAS MADE FROM THE SAMPLE AND THE RESULT WAS 2211 PG/ML. THE INITIAL RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848872 ↗
• MalfunctionAug 4, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULT FROM PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). ON (B)(6) 2025, THE INITIAL RESULT WAS >3000 PG/ML WITH A DATA FLAG. ON (B)(6) 2025, THE REPEAT RESULT WAS 19.48 PG/ML. ON (B))(6) 2025, THE REPEAT RESULT WAS 24.90 PG/ML. THE PATIENT QUESTIONED THE INITIAL RESULT, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703543 ↗
• MalfunctionJul 15, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III) AND ELECSYS FSH (FSH) ON A COBAS 6000 E601 MODULE. THE ESTRADIOL III RESULT FROM THE E601 MODULE WAS 769.20 PMOL/L. THE SAMPLE WAS REPEATED TWICE ON THE E601 MODULE WITH RESULTS OF 800.8 PMOL/L AND 804.6 PMOL/L. THE FSH RESULT FROM THE E601 MODULE WAS 1.31 IU/L. THE DOCTOR QUESTIONED THE ESTRADIOL RESULT AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S CONDITION. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD, AND THE ESTRADIOL RESULT WAS < 55.1 PMOL/L, AND THE FSH RESULT WAS 1.85 MIU/ML. THIS MEDWATCH WILL COVER ESTRADIOL III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT- (B)(6) FOR INFORMATION ON THE FSH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506723 ↗
• MalfunctionJul 15, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS AND ISSUES WITH CALIBRATION FOR THE ELECSYS ESTRADIOL III ASSAY FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 5198 PG/ML. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S HISTORY. ON (B)(6) 2025, THE REPEAT RESULT WAS 2873 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506341 ↗
• MalfunctionJul 11, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 4550 PMOL/L. THE SAMPLE WAS REPEATED AND MANUALLY DILUTED 11X WITH DIL.MULTIASSAY, GENERATING A RESULT OF 4117.3 PMOL/L. THE INITIAL SAMPLE WAS SENT TO ANOTHER LABORATORY AND ANALYZED ON A COMPETITOR'S INSTRUMENT, GENERATING A RESULT OF APPROXIMATELY 4000 PMOL/L. A FEW DAYS LATER, A SECOND SAMPLE FROM THE SAME PATIENT WAS OBTAINED, GENERATING A RESULT BELOW THE LIMIT OF DETECTION (<18.4 PMOL/L). THE ANALYSIS WAS REPEATED WITH THE SAME RESULT. IT WAS INDICATED THAT THE INITIAL HIGH RESULT DID NOT CORRESPOND TO THE CLINICAL STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479067 ↗
• MalfunctionJul 1, 2025Unable to Obtain Readings; High Test Results; Low Test Results; Non Reproducible Results; Unable to Obtain Readings; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). ON (B)(6) 2025: THE INITIAL RESULT WITH THE PATIENT SAMPLE IN THE ORIGINAL TUBE WAS <0.5 PG/ML. ON (B)(6) 2025: THE FIRST REPEAT RESULT WITH THE PATIENT SAMPLE IN THE ORIGINAL TUBE WAS 78.77 PG/ML. ON (B)(6) 2025: THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE IN A HITACHI CUP WAS 22.51 PG/ML. THE THIRD REPEAT RESULT WITH THE PATIENT SAMPLE IN THE ORIGINAL TUBE WAS 8.07 PG/ML. THE FOURTH REPEAT RESULT WITH THE PATIENT SAMPLE IN A HITACHI CUP WAS 22.0 PG/ML. THE DOCTOR QUESTIONED THE INITIAL RESULT, PROMPTING THE PATIENT'S SAMPLE TO BE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370265 ↗
• MalfunctionJun 20, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ESTRADIOL III ASSAY ON AN UNKNOWN ROCHE ANALYZER. THE CUSTOMER HAS REPORTED THE ISSUE IN VOLUNTARY MEDWATCH MDR REPORT NUMBER MW5170621. THE SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF 219 PG/ML. THE ENDOCRINOLOGIST QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN A VALUE OF < 5 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296734 ↗
• MalfunctionJun 12, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FROM THE COBAS E411 DISK ANALYZER. THE INITIAL RESULT WAS >3000 PG/ML. ON (B)(6) 2025, THE RESULT FROM A 1:10 DILUTION WAS 413.9 PG/ML. IT WAS NOTED THAT THE CUSTOMER USED "UNIVERSAL DILUTE" INSTEAD OF THE DILUENT MULTIASSAY STATED IN THE PRODUCT LABELING FOR THE ASSAY. THE RESULT FROM ANOTHER COBAS 8000 ANALYZER WAS 2547 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192855 ↗