Elecsys Vitamin D total IIIRecalls & reported problems across all models

We found 2 models of Elecsys Vitamin D total III by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2022 and Sep 23, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “High Test Results” (38 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 Vitamin D total III problems

Elecsys Vitamin D total III models

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

• Elecsys Vitamin D total III 09038086190

  SYSTEM, TEST, VITAMIN D
  42 reports
• Elecsys Vitamin D total III 09038078160

  SYSTEM, TEST, VITAMIN D
  8 reports

Recent Elecsys Vitamin D total III adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873000 ↗
• MalfunctionApr 8, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS VITAMIN D TOTAL III ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 101 NG/ML (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT WAS 56.3 NG/ML WITH A DIFFERENT REAGENT LOT 881659. THE SAMPLE WAS REPEATED ON THE COBAS 6000 INSTRUMENT AND THE RESULT WAS 32.59 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816402 ↗
• MalfunctionMar 31, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FOR 2 PATIENT SAMPLES TESTED ON A COBAS E 801 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL RESULT WAS <3.0 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON AN ATELLICA SYSTEM ANALYZER, AND THE RESULT WAS 14.68 NG/ML. FOR SAMPLE 2, THE INITIAL RESULT WAS 3.25 NG/ML. THE SAMPLE WAS REPEATED ON AN ATELLICA SYSTEM ANALYZER, AND THE RESULT WAS 12.88 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744366 ↗
• MalfunctionMar 25, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS >120 NG/ML. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 31.1 NG/ML. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULT WAS 31.1 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689355 ↗
• MalfunctionMar 18, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D, TOTAL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 99.1 NG/ML. ON (B)(6) 2026, THE REPEATED RESULT WAS 32.9 NG/ML (REPORTED AS 33 NG/ML). THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627855 ↗
• MalfunctionMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS; VITAMIN D TOTAL III RESULTS, FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 29 NG/ML. THIS RESULT WAS QUESTIONED AS THE PATIENT IS ON VITAMIN D SUPPLEMENTATION. THE REPEAT RESULT USING ANOTHER (UNKNOWN) PLATFORM WAS 82.6 NG/ML. ON (B)(6) 2026, THE REPEAT RESULT WAS 76.3 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594710 ↗
• MalfunctionMar 10, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN D TOTAL III (VITAMIN D TOTAL III) ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS >120 NG/ML, WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH A RESULT OF 79.57 NG/ML. A RESULT OF 80 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS BELIEVED TO BE CORRECT BASED ON THE PATIENT¿S HISTORICAL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556184 ↗
• MalfunctionFeb 26, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 7 PATIENTS' SAMPLES TESTED WITH ELECSYS VITAMIN D TOTAL III ASSAY ON A COBAS PURE E 402 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 117 NG/ML. 1ST REPEAT RESULT: 22 NG/ML. 2ND REPEAT RESULT: 24 NG/ML (TESTED WITH THE NEW REAGENT PACK). SAMPLE 2: INITIAL RESULT: 82.8 NG/ML. 1ST REPEAT RESULT: 31.7 NG/ML. 2ND REPEAT RESULT: 34.72 NG/ML (TESTED WITH THE NEW REAGENT PACK). SAMPLE 3: INITIAL RESULT: >120 NG/ML. 1ST REPEAT RESULT: 46.3 NG/ML. 2ND REPEAT RESULT: 49.44 NG/ML (TESTED WITH THE NEW REAGENT PACK). SAMPLE 4: INITIAL RESULT: 78.6 NG/ML. REPEAT RESULT: 23.7 NG/ML (TESTED WITH THE NEW REAGENT PACK). SAMPLE 5: INITIAL RESULT: 93.1 NG/ML. REPEAT RESULT: 30.9 NG/ML (TESTED WITH THE NEW REAGENT PACK). SAMPLE 6: INITIAL RESULT: 62.4 NG/ML. REPEAT RESULT: 28.3 NG/ML (TESTED WITH THE NEW REAGENT PACK). ON (B)(6) 2026: SAMPLE 7: INITIAL RESULT: >120 NG/ML. REPEAT RESULT: 50.4 NG/ML. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24459975 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN D TOTAL III (VITAMIN D III) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 120 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 32.7 NG/ML AND 37.5 NG/ML. A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 37.1 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441927 ↗
• MalfunctionFeb 11, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE REPORTED LINE WAS 111 NG/ML WITH A DATA FLAG. THIS RESULT WAS CONSIDERED FALSELY ELEVATED. THE FIRST REPEAT RESULT FROM ANOTHER LINE BY AUTOMATIC RERUN WAS 68.3 NG/ML. THE SECOND REPEAT RESULT FROM THE REPORTED LINE BY A MANUAL RERUN WAS 71.8 NG/ML. THE THIRD REPEAT RESULT FROM THE OTHER LINE WAS 68.9 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316327 ↗
• MalfunctionFeb 3, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS VITAMIN D TOTAL III ON A COBAS E 801 ANALYTICAL UNIT. ALL PATIENT SAMPLES INITIALLY RECOVERED VALUES AROUND 100 NG/ML. WHEN THE REAGENT PACK WAS EXHAUSTED, A NEW REAGENT PACK WAS PLACED INTO USE. THE PATIENT SAMPLES WERE REPEATED USING THE NEW REAGENT PACK AND DISCREPANCIES WERE OBSERVED. THE CUSTOMER PROVIDED EXAMPLES OF FOUR PATIENT SAMPLES WITH DISCREPANT VITAMIN D RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 101 NG/ML AND IT REPEATED AS 9.31 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 91.4 NG/ML AND IT REPEATED AS 9.96 NG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 113 NG/ML AND IT REPEATED AS 59.4 NG/ML. THE FOURTH SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 102 NG/ML AND IT REPEATED AS 17.7 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243955 ↗
• MalfunctionJan 15, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 120 NG/ML WITH A DATA FLAG. THIS RESULT WAS CONSIDERED FALSELY HIGH. THE REPEATED RESULT WAS 31 NG/ML. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DIDN'T MATCH THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082476 ↗
• MalfunctionJan 13, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS VITAMIN D TOTAL III ON A COBAS E 801 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 116 NG/ML. THE RESULT DID NOT AGREE WITH THE PATIENT'S HISTORY, SO THE CUSTOMER DECIDED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN VITAMIN D VALUES OF 20.9 NG/ML AND 19.7 NG/ML. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064339 ↗
• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE VITAMIN D TOTAL III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866277 ↗
• MalfunctionDec 8, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Contamination; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 6.18 NG/ML. THE REPEAT RESULT ON (B)(6) 2025 WAS 16.9 NG/ML. PATIENT 2'S INITIAL RESULT WAS 11.1 NG/ML. THE REPEAT RESULT ON (B)(6) 2025 WAS 20.7 NG/ML. THE SAMPLES WERE REPEATED WHEN THE CUSTOMER NOTICED THAT MULTIPLE RESULTS WERE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741510 ↗

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