Elecsys Estradiol IIIRecalls & reported problems across all models

We found 2 models of Elecsys Estradiol III by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2018 and Sep 29, 2026 — classified as 1 injury, 161 malfunctions.

The most frequently reported specific device problem is “High Test Results” (113 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys Estradiol III problems

Elecsys Estradiol III models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys Estradiol III 6656021190

  RADIOIMMUNOASSAY, ESTRADIOL
  101 reports
• Elecsys Estradiol III 07027249190

  RADIOIMMUNOASSAY, ESTRADIOL
  61 reports

Recent Elecsys Estradiol III adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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