Elecsys Estradiol III 07027249190Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 04015630939671), received between Nov 12, 2018 and Sep 29, 2026 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “High Test Results” (43 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931324 ↗
• MalfunctionSep 10, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714527 ↗
• MalfunctionAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50259958 ↗
• MalfunctionJun 8, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS ESTRADIOL III ON A COBAS E 801 ANALYTICAL UNIT AND AN UNKNOWN ROCHE ANALYZER AT A SECOND SITE. THE FIRST SAMPLE RESULTED IN AN ESTRADIOL VALUE OF 105 PG/ML WHEN TESTED ON THE CUSTOMER'S E 801 ANALYZER. THE PATIENT'S DOCTOR QUESTIONED THE VALUE AS THE PATIENT HAD A HISTORY OF BREAST CANCER. THE PATIENT HAD UNDERGONE A MASTECTOMY AND BILATERAL OOPHORECTOMY. THE ESTRADIOL RESULT WAS EXPECTED NOT TO BE MEASURABLE. THE FIRST SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED USING THE SAME ROCHE METHOD ON AN UNKNOWN ANALYZER. THE ESTRADIOL RESULT WAS THE SAME. NO SPECIFIC DATA WAS PROVIDED. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN ESTRADIOL VALUE OF 161 PG/ML ON (B)(6) 2026. THIS SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH THE ABBOTT ESTRADIOL METHOD. WHEN TESTED WITH THE ABBOTT METHOD, THE ESTRADIOL RESULT WAS < 20 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25432238 ↗
• MalfunctionMay 13, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1563 NG/L. THE REPEAT RESULT WAS 776 NG/L. THE TEST WAS REPEATED AS THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159647 ↗
• MalfunctionMay 12, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. FOR ONE SAMPLE, THE INITIAL RESULT WAS 122 PG/ML. APPROXIMATELY 0.5-1 HOUR LATER, THE SAMPLE WAS REPEATED, AND THE RESULT WAS 43.8 PG/ML. THE CUSTOMER'S LIS CALCULATED THE AVERAGE OF MEASUREMENTS, AND A RESULT OF 82.9 PG/ML WAS RELEASED AS THE FINAL. THIS PROMPTED A PHYSICIAN TO REQUEST FURTHER REVIEW, AS A LOWER ESTRADIOL RESULT WAS EXPECTED FOR THIS PATIENT. THE NEXT DAY, THE SAMPLE WAS REPEATED, AND THE RESULTS WERE 43.8 PG/ML AND 44.8 PG/ML. THE CUSTOMER BELIEVED THESE RESULTS FIT THE CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152208 ↗
• MalfunctionMay 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF INTERFERENCE FROM MEDICATION AFFECTING AN ELEVATED ELECSYS ESTRADIOL III RESULT FROM TWO COBAS E 801 ANALYTICAL UNITS FOR ONE PATIENT. THE PATIENT'S RESULT ON (B)(6) 2026 FROM ANALYZER A WAS 3087 PMOL/L, USING REAGENT LOT NUMBER 858578. THE PATIENT'S RESULT ON (B)(6) 2026 FROM ANALYZER B WAS 3373 PMOL/L, USING REAGENT LOT NUMBER 858578. THE PATIENT'S RESULT ON (B)(6) 2026 WAS 1832 PMOL/L, USING REAGENT LOT NUMBER 887565. IT WAS NOT PROVIDED WHICH ANALYZER THIS RESULT WAS FROM. THIS SAMPLE WAS SENT TO ANOTHER HOSPITAL THAT USES A SIEMENS ANALYZER, AND THE RESULT WAS 1782 PMOL/L. THE SIEMENS RESULT WAS COMPARABLE TO THE ROCHE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125875 ↗
• MalfunctionApr 20, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. PATIENT SAMPLE 1 ON (B)(6) 2026: THE INITIAL RESULT FROM THE ANALYZER WAS 499 PG/ML. THE REPEAT RESULT FROM A COMPETITOR ANALYZER WAS 39 PG/ML. PATIENT SAMPLE 2 ON (B)(6) 2026: THE INITIAL RESULT WAS 216.0 PG/ML. THE INITIAL RESULT WAS DEEMED IMPLAUSIBLE, PROMPTING RERUNS. THE FIRST REPEAT RESULT WAS 27.7 PG/ML. THE SECOND REPEAT RESULT WAS 27.5 PG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931624 ↗
• MalfunctionApr 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II), ELECSYS ESTRADIOL III (ESTRADIOL III), AND ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE SIEMENS METHOD AND LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC-MS). THIS MEDWATCH WILL COVER ESTRADIOL III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-(B)(6) FOR INFORMATION ON THE TESTOSTERONE II RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER PT-(B)(6) FOR INFORMATION ON THE PROLACTIN II RESULTS. THE TESTOSTERONE II RESULT FROM THE E801 ANALYZER WAS 52.0 NMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 25 NMOL/L. THE LC-MS RESULT WAS 17.7 NMOL/L. THE ESTRADIOL III RESULT FROM THE E801 ANALYZER WAS 474 PMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.16 PMOL/L. THE PROLACTIN II RESULT FROM THE E801 ANALYZER WAS 265 MU/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.17 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877123 ↗
• MalfunctionFeb 18, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR ONE PATIENT SAMPLE TESTED ON TWO COBAS E 801 ANALYTICAL UNITS (COBAS A AND COBAS B). THE INITIAL RESULT FROM COBAS A IS >11010 PMOL/L. THE REPEAT RESULT AFTER AUTOMATIC DILUTION IS 1110 PMOL/L. THE REPEAT RESULT FROM COBAS B IS <18.4 PMOL/L. THE REPEAT RESULT AFTER MANUAL DILUTION IS 668 PMOL/L (THE DILUTION COMPUTATION IS 66.8 X 10). NO RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376248 ↗
• MalfunctionFeb 10, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR 2 SAMPLES FROM THE COBAS E 801 MODULE. SAMPLE 1 INITIAL RESULT WAS <0.6 PMOL/L. THE REPEAT RESULT USING THE SAME ANALYZER WAS 480 PMOL/L. THE REPEAT RESULTS FROM ANOTHER E801 ANALYZER WERE 14.9 PMOL/L, 14.3 PMOL/L, 11010 PMOL/L, AND 24013 PMOL/L. SAMPLE 2 INITIAL RESULT WAS 2559 PMOL/L. THE REPEAT RESULTS FROM ANOTHER E801 ANALYZER WERE 11010 PMOL/L, 11010 PMOL/L, 11010 PMOL/L, AND 25168 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307433 ↗
• MalfunctionFeb 6, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ESTRADIOL III ON A COBAS PURE E 402 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF 173 PG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 37.1 PG/ML AND 37.2 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277212 ↗
• MalfunctionFeb 5, 2026Incorrect Measurement; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 13.8 PG/ML. THE REPEATED RESULTS WERE 31 PG/ML AND 12.4 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270709 ↗
• MalfunctionFeb 2, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 10.6 PG/ML WITH A DATA FLAG. THE REPEATED RESULT WAS 11.9 PG/ML WITH A DATA FLAG. THE SAMPLE WAS DILUTED, AND THE RESULTS WERE: 27.9 PG/ML (1:2 RATIO), 71.2 PG/ML (1:5 RATIO), 391 PG/ML (1:20 RATIO), AND 1905 PG/ML (1:100 RATIO). THE INITIAL RESULT OF 10.6 PG/ML WAS DEEMED CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE RESULTS HAD DATA FLAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236079 ↗
• MalfunctionJan 9, 2026Chemical Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS ESTRADIOL III ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 126 PG/ML. 1ST REPEAT RESULT: 13.01 PG/ML (TESTED ON ABBOTT). 2ND REPEAT RESULT: 80.71 PG/ML (TESTED ON ROCHE E 602 AT A DIFFERENT FACILITY). SAMPLE 2: ON (B)(6) 2025: INITIAL RESULT: 139 PG/ML. 1ST REPEAT RESULT: 19.5 PG/ML (TESTED ON ABBOTT). 2ND REPEAT RESULT: 104.3 PG/ML (TESTED ON ROCHE E 602 AT A DIFFERENT FACILITY). THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, PROMPTING THE REPEAT OF THE SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020151 ↗
• MalfunctionDec 19, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 19.4 PG/ML. THE PHYSICIAN QUESTIONED THE RESULT, AND THE SAMPLE WAS REPEATED ON ANOTHER E 801 MODULE. THE REPEATED RESULT WAS 19.4 PG/ML. NEITHER RESULT WAS BELIEVED TO BE CORRECT BECAUSE A HIGHER RESULT WAS EXPECTED FOR THE PATIENT. THE SAMPLE WAS REPEATED WITH A 1:2 DILUTION, AND THE RESULT WAS "STILL IN LINE WITH THE UNDILUTED MEASUREMENTS." THE NUMERICAL RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED WITH A 1:10 DILUTION, AND THE RESULT WAS 250 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850159 ↗
• MalfunctionDec 9, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT, A COBAS E 602 MODULE, AND A COBAS E 411 ANALYZER COMPARED TO 2 COMPETITOR ANALYZERS. ON (B)(6) 2025, THE SAMPLE WAS TESTED TWICE ON THE E 801 ANALYZER AND THE RESULTS WERE 699 PMOL/L AND 712 PMOL/L. ON (B)(6) 2025, THE SAMPLE WAS TESTED TWICE ON A SNIBE MAGLUMI ANALYZER AND THE RESULTS WERE 53.6 PMOL/L AND 64.1 PMOL/L. ON (B)(6) 2025, THE SAMPLE WAS TESTED ON THE E 801 ANALYZER AGAIN AND THE RESULT WAS 693 PMOL/L. ON (B)(6) 2025, THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON AN E 602 ANALYZER AND THE RESULT WAS 662.8 PMOL/L. ON (B)(6) 2025, THE SAME PATIENT HAD A NEW SAMPLE COLLECTED AND THE INITIAL RESULT FROM THE E 801 ANALYZER WAS 352 PMOL/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 372 PMOL/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON AN E 411 ANALYZER AND THE RESULT WAS 453.0 PMOL/L. ON (B)(6) 2025, THE SAMPLE WAS TESTED ON A SNIBE MAGLUMI ANALYZER AND THE RESULT WAS 33.5 PMOL/L. THE SAMPLE WAS ALSO TESTED ON AN ABBOTT ALINITY AND THE RESULT WAS <88.1 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758943 ↗
• MalfunctionDec 5, 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 RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 26.6 PMOL/L, AND THE REPEAT RESULT WAS 279 PMOL/L. SAMPLE 2 INITIAL RESULT WAS 210 PMOL/L, AND THE REPEAT RESULT WAS 18.8 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729090 ↗
• MalfunctionNov 21, 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 PURE E 402 ANALYTICAL UNIT. INITIAL RESULT: 740 PG/ML. 1ST REPEAT RESULT: 49.1 PG/ML. 2ND REPEAT RESULT: 48.4 PG/ML. ON (B)(6) 2025: THE SAMPLE WAS REPEATED ON A DELTA INSTRUMENT, RESULTING IN A 3RD REPEAT RESULT OF 57.2 PG/ML. THE SAMPLE WAS REPEATED 10 MORE TIMES ON A DIFFERENT COBAS PURE ANALYTICAL UNIT, RESULTING IN THE FOLLOWING REPEAT RESULTS: 46.2 PG/ML, 51.2 PG/ML, 47.9 PG/ML, 46.6 PG/ML, 47.4 PG/ML, 46.8 PG/ML, 47.2 PG/ML, 46.4 PG/ML, 48.3 PG/ML, AND 47.2 PG/ML. THE RESULT THAT WAS CONSIDERED CORRECT WAS AROUND 50 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622046 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER RECEIVED TWO DIFFERENT SAMPLE TUBES FOR THE SAME PATIENT THAT WERE DRAWN AT THE SAME TIME. THE SAMPLES WERE BOTH TESTED ON THE SAME MODULE. SAMPLE 1 RESULT WAS 401 PMOL/L. SAMPLE 2 RESULT WAS 286 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619237 ↗
• MalfunctionNov 11, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY AND ELECSYS ESTRADIOL III RESULTS FOR ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER THE ELECSYS ESTRADIOL III ASSAY. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS TESTOSTERONE II ASSAY. THE PATIENT HAD BEEN CONTINUOUSLY MONITORED FOR OVER THREE MONTHS AND HAD CONSISTENTLY ELEVATED RESULTS FROM THREE E 801 ANALYZERS. THE PATIENT WENT TO ANOTHER HOSPITAL FOR TESTING AND REPORTED TO THE CLINICIAN THAT THE RESULTS FROM A SIEMENS ANALYZER WERE NORMAL. ON (B)(6) 2025, THE PATIENT HAD NEW SAMPLES COLLECTED. THE TESTOSTERONE RESULT FROM THE ANALYZER WAS 3.39 NMOL/L. THE TESTOSTERONE RESULT FROM A MASS SPECTROMETRY ANALYZER WAS 1.401 NMOL/L. THE ESTRADIOL RESULT FROM THE ANALYZER WAS 2444 PMOL/L. THE ESTRADIOL RESULT FROM A MASS SPECTROMETRY ANALYZER WAS 896 PMOL/L. THE MASS SPECTROMETRY RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE REPORTER SUSPECTS AN INTERFERENT IN THE PATIENT'S SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524617 ↗
• MalfunctionOct 28, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE RESULT FROM SAMPLE 1 WAS 2462 PG/ML. ON (B)(6) 2025, THE RESULT FROM A NEW SAMPLE FROM THE PATIENT WAS LOW. NO SPECIFIC DATA WAS PROVIDED. ON (B)(6) 2025, SAMPLE 1 WAS REPEATED, AND THE RESULTS WERE 259 PG/ML AND 258 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402895 ↗
• MalfunctionJul 28, 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 QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM THE COBAS E 801 MODULE. PATIENT 1 HAD AN INITIAL RESULT OF 118 PMOL/L AND A REPEAT RESULT OF 155 PMOL/L. PATIENT 2 HAD AN INITIAL RESULT OF 170 PMOL/L AND A REPEAT RESULT OF 214 PMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628871 ↗
• MalfunctionJul 11, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT THAT DID NOT MATCH THE CLINICAL PICTURE. THE RESULT FOR ONE SAMPLE FROM THE PATIENT WAS 6.40 PG/ML. ANOTHER SAMPLE DRAWN FROM THE PATIENT ON THE SAME DATE AS THE ORIGINAL SAMPLE WAS TESTED ON (B)(6) 2025 WITH A RESULT OF 33.8 PG/ML AND WAS TESTED ON (B)(6) 2025 WITH A RESULT OF 33.1 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478462 ↗
• MalfunctionJul 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ESTRADIOL III RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6)2026: THE INITIAL RESULT WAS 369.0 ON (B)(6) 2026: THE REPEAT RESULT WAS 66.6. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411086 ↗