Elecsys Vitamin D total III 09038078160Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613336184615), received between Mar 31, 2023 and Mar 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 5, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON TWO COBAS 6000 E601 MODULES (COBAS 1 AND COBAS 2). ONE PATIENT SAMPLE WITH DISCREPANT RESULTS WAS PROVIDED: RESULTS FROM THE COBAS 1: THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 120.0 NG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 120.0 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT MANUAL 1:2 DILUTION WAS 120.0 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT MANUAL 1:10 DILUTION WAS 23.30 NG/ML WITH A FINAL CALCULATED RESULT OF 233.0 NG/ML. RESULTS FROM COBAS 2: THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 120.0 NG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 120.0 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT MANUAL 1:2 DILUTION WAS 120.0 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT MANUAL 1:10 DILUTION WAS 23.44 NG/ML WITH A FINAL CALCULATED RESULT OF 234.4 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525950 ↗
• MalfunctionApr 1, 2024Incorrect, 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 VITAMIN D TOTAL G3 ( VITAMIN D TOTAL III) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E 601 (UL) V. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE QC RESULTS FLAGGED PROMPTING THE RERUN OF THE PATIENT SAMPLES. SAMPLE 33930A-0312 THE INITIAL RESULT WAS 65 NG/ML. THE REPEAT RESULT WAS 21 NG/ML. SAMPLE 34113F-0312 THE INITIAL RESULT WAS 112 NG/ML. THE REPEAT RESULT WAS 38 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014135 ↗
• MalfunctionFeb 27, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SERUM SAMPLES TESTED WITH ELECSYS VITAMIN D TOTAL G3 ( VITAMIN D TOTAL III) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: >80 NG/ML. REPEAT RESULT: 14.2 NG/ML. SAMPLE 2 (PATIENT 2) WAS TESTED ON (B)(6) 2024: INITIAL RESULT: >80 NG/ML. REPEAT RESULT: 26.0 NG/ML. THE PHYSICIAN QUESTIONED THE RESULTS. THE SAMPLES WERE THEN REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787498 ↗
• MalfunctionDec 14, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL VITAMIN D RESULT WAS >120 NG/ML WITH FLAG. THE SAMPLE WAS REPEATED AS THE CUSTOMER HAS AN INTERNAL POLICY TO REPEAT ALL VITAMIN D RESULTS ABOVE 120 NG/ML. A 1:2 MANUAL DILUTION WAS MADE OF THE SAMPLE AND THE RESULT WAS 74 NG/ML. A SECOND 1:2 MANUAL DILUTION WAS MADE OF THE SAMPLE AND THE RESULT WAS 62.66 NG/ML. THE REPEAT RESULT OF 62.66 NG/ML WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326079 ↗
• MalfunctionJun 9, 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 ELECSYS VITAMIN D TOTAL III ON COBAS E411 RACK ANALYZER SERIAL NUMBER (B)(6). THE PATIENT SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 19.36 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 29.45 NG/ML. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100318 ↗
• MalfunctionMay 12, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THAT STARTING (B)(6) 2023 THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE ELECSYS VITAMIN D TOTAL III ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(6). THE REPORTER ALSO MENTIONED QUALITY CONTROL ISSUES. OF THE DATA PROVIDED, FOUR PATIENT SAMPLES RECEIVED DISCREPANT RESULTS WITH ELECSYS VITAMIN D TOTAL III ASSAY: PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A VITAMIN D TOTAL III VALUE OF 45.8 NG/ML AND REPEATED AS 29.4 NG/ML. PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A VITAMIN D TOTAL III VALUE OF 61.7 NG/ML AND REPEATED AS 35.6 NG/ML. PATIENT SAMPLE 3: THE SAMPLE INITIALLY RESULTED IN A VITAMIN D TOTAL III VALUE OF 44.8 NG/ML AND REPEATED AS 28.9 NG/ML. PATIENT SAMPLE 4: THE SAMPLE INITIALLY RESULTED IN A VITAMIN D TOTAL III VALUE OF > 120 NG/ML ACCOMPANIED BY A DATA FLAG AND REPEATED AS 53.3 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT. THE QUESTIONABLE RESULTS OF PATIENT SAMPLES 1, 2, AND 3 WERE REPORTED OUTSIDE OF THE LABORATORY AND AN AMENDED REPORT WAS ISSUED. THE QUESTIONABLE RESULT OF PATIENT SAMPLE 4 WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919265 ↗
• MalfunctionMar 31, 2023Degraded; High Test Results; Material Integrity Problem; Non Reproducible Results; Degraded; High Test Results; Material Integrity Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH VITAMIN D TOTAL G3 (VITAMIN D3) ASSAY ON A COBAS 6000 E601. ON (B)(6) 2023 THE CUSTOMER RAN THE PATIENTS' SAMPLES AND REPORTED THE FOLLOWING RESULTS: SAMPLE 1: RUN 1: 120 NG/ML TEST, RERUN 1: 7.55 NG/ML, RERUN 2: 6.55 NG/ML. SAMPLE 2: RUN 1: 120 NG/ML TEST, RERUN 1: 23.20 NG/ML, RERUN 2: 24.35 NG/ML. THE RESULTS OF 120 NG/ML TEST WERE REPORTED OUTSIDE OF THE LABORATORY BUT THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. SO IT WAS REPEATED. THE RESULT THAT WAS DEEMED TO BE CORRECT FOR SAMPLE 1 WAS 7.55 NG/ML. THE VITAMIN D3 LOT NUMBER WAS 662797. THE EXPIRATION DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659186 ↗