Elecsys Vitamin D total III 09038086190Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613336172650), received between Nov 30, 2022 and Sep 23, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “High Test Results” (32 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 42 reports, 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 ↗
• 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 ↗
• MalfunctionNov 13, 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 VITAMIN D TOTAL III ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). INITIAL RESULT: 116.8 NG/ML. THE SAMPLE WAS REPEATED TWICE. 1ST REPEAT RESULT: 22 NG/ML. 2ND REPEAT RESULT: 23 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544500 ↗
• MalfunctionAug 13, 2025Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 9 PATIENT SAMPLES TESTED WITH ELECSYS VITAMIN D TOTAL III ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER NOTED THAT DUE TO A SAMPLE FROM A PATIENT WITH HYPERGLOBULINEMIA, A BLOCKAGE OCCURRED IN THE SIPPER PROBE TUBING. THE CUSTOMER PERFORMED AN EXPERIMENT WITH THE SAMPLE NOTING THAT THE SAMPLE RAPIDLY FORMED A JELLY-LIKE CLOT UPON ADDITION OF VITAMIN D REAGENT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE FROM THE PATIENT WITH HYPERGLOBULINEMIA INITIALLY RESULTED IN A VITAMIN D VALUE OF > 300 NMOL/L. THIS SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF > 320 NMOL/L AND < 7.5 NMOL/L. THE SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL AND TESTED, RESULTING IN A VALUE OF 125 NMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF > 300 NMOL/L AND IT REPEATED AS 48 NMOL/L. THE THIRD SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 237 NMOL/L AND IT REPEATED AS 40.7 NMOL/L. THE FOURTH SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 236 NMOL/L AND IT REPEATED AS 57.6 NMOL/L. THE FIFTH SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF 107 NMOL/L AND IT REPEATED AS 40.2 NMOL/L. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796425 ↗
• MalfunctionJul 22, 2025Low Test Results; Non Reproducible Results; Low 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 E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 20.7 NG/ML. THE DOCTOR COMPLAINED THAT THE RESULT SHOULD BE HIGHER. ON (B)(6) 2025, THE SAMPLE WAS REPEATED WITH A RESULT OF 50.0 NG/ML. THE SAMPLE WAS REPEATED IN A HITACHI CUP, AND THE RESULT WAS 50.7 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563829 ↗
• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High 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. THE SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF > 300 NMOL/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 42 NMOL/L. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A VITAMIN D VALUE OF 31.5 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876533 ↗
• MalfunctionMar 18, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FOR APPROXIMATELY 70 PATIENT SAMPLES ON A COBAS 8000 E 801 MODULE. THE FOLLOWING ARE THREE EXAMPLES OF DISCREPANT RESULTS: PATIENT 1: THE INITIAL RESULT WAS 300 NMOL/L WITH A DATA FLAG. THE REPEATED RESULT WAS 58.1 NMOL/L. THE DOCTOR QUESTIONED THE RESULTS AND THE CUSTOMER NOTED PATIENT 1'S HIGH TOTAL PROTEIN RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLES. PATIENT 2: THE INITIAL RESULT WAS 86.3 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2025 AND THE RESULT WAS 7.5 NMOL/L WITH A DATA FLAG. PATIENT 3: THE INITIAL RESULT WAS 300 NMOL/L WITH A DATA FLAG. THE REPEATED RESULT WAS 178 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2025 AND THE RESULT WAS 153 NMOL/L. THE SAMPLES WERE REPEATED AFTER THE PHYSICIAN QUESTIONED THE INITIAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635833 ↗
• MalfunctionMar 5, 2025High Test Results; Insufficient Device Problem Information; High Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS WERE REPORTED: SAMPLE 1 ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 161 NG/ML. ON (B)(6) 2025: THE REPEAT RESULT FROM ANOTHER LABORATORY THAT USES THE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY (LC-MS/MS) METHOD WAS 52 NG/ML (NO DETECTABLE VITD2). SAMPLE 2 ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 223 NG/ML. ON (B)(6) 2025: THE REPEAT RESULT FROM THE OTHER LABORATORY'S LC-MS/MS METHOD WAS 80 NG/ML (NO DETECTABLE VITD2). THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' CLINIC PICTURES, PROMPTING THE PATIENT SAMPLE RERUNS. THE REPEAT RESULTS WERE DEEMED CORRECT. SAMPLE 3 ON (B)(6) 2025: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE FROM THE ANALYZER WAS 113 NG/ML. THIS RESULT WAS QUESTIONED, PROMPTING THE PATIENT SAMPLE RERUN. THE FIRST REPEAT RESULT FROM A SECOND E 801 ANALYZER WAS 118 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT FROM A THIRD E 801 ANALYZER WAS 130 NG/ML WITH A DATA FLAG. ON (B)(6) 2025: THE RESULT OF ANOTHER PATIENT SAMPLE FROM THE OTHER LABOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526295 ↗
• MalfunctionOct 9, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. THE PATIENT'S DOCTOR QUESTIONED THE PATIENT RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE INITIAL VITAMIN D RESULT WAS 332 NG/ML. A 1:5 DILUTION OF THE PATIENT SAMPLE WAS PERFORMED AND THE RESULT WAS ABOVE 300 NG/ML. THE EXACT RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408108 ↗
• MalfunctionAug 20, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 207 NMOL/L. THE REPEATED RESULT WAS 48.7 NMOL/L. ADDITIONAL RESULTS WERE PROVIDED FROM (B)(6) 2024. IT IS UNKNOWN IF THE RESULTS WERE FROM THE SAME PATIENT SAMPLE. THE ADDITIONAL VITAMIN D RESULTS WERE: 83.9 NMOL/L, 81.8 NMOL/L, 82.4 NMOL/L, 83.9 NMOL/L, 84.2 NMOL/L, 81.7 NMOL/L, 79.0 NMOL/L, 80.4 NMOL/L, AND 184 NMOL/L. THE PATIENT IS KNOWN TO HAVE A VITAMIN D RESULT OF APPROXIMATELY 60 NMOL/L OR 80 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005210 ↗
• MalfunctionJun 17, 2024High Test Results; Non Reproducible Results; High 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. THE SAMPLE INITIALLY RESULTED IN A VITAMIN D VALUE OF > 120 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VITAMIN D VALUE OF 24.1 NG/ML. THE SAMPLE WAS ALSO REPEATED USING A DIFFERENT UNKNOWN METHOD, RESULTING IN A VITAMIN D VALUE OF 36 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547172 ↗
• MalfunctionApr 26, 2024High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D ASSAY RESULTS FOR 2 PATIENT HEPARIN SAMPLES FROM 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL VITAMIN D RESULT WAS >120 NG/DL WITH FLAG. A 1:2 DILUTION WAS PERFORMED ON THE SAMPLE AND RESULT WAS 11 NG/ML. THE CUSTOMER PERFORMED A 5 REPETITION PRECISION TEST ON THE SAMPLE AND THE RESULTS WERE 108 NG/ML, >120 NG/ML WITH FLAG, 115 NG/ML, 53.1 NG/ML, AND 97.5 NG/ML. A 1:2 DILUTION WAS PERFORMED ON THE SAMPLE AND ANOTHER 5 REPETITION PRECISION TEST WAS PERFORMED. THE RESULTS WERE 9.04 NG/ML, 8.7 NG/ML, 10.8 NG/ML, 8.72 NG/ML, AND 7.36 NG/ML. A SECOND TUBE COLLECTED FROM THE SAME PATIENT AT THE SAME TIME WAS SENT TO ANOTHER LABORATORY AND TESTED ON ANOTHER ANALYZER. THE RESULT WAS 11 NG/ML. THE OTHER LAB'S REFERENCE RANGE IS 30-40 NG/ML. THE SECOND SAMPLE WAS ALSO TESTED FOUR TIMES AT THE CUSTOMER SITE AND THE RESULTS WERE 46.0 NG/ML, 29.8 NG/ML, 40.8 NG/ML, AND 33.1 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM THE OTHER LABORATORY WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192637 ↗
• MalfunctionMar 26, 2024Low Test Results; Low Readings; Non Reproducible Results; Low Test Results; Low Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D ASSAY RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL VITAMIN D RESULT OF 11.6 NG/ML. ON (B)(6) 2024, THE CUSTOMER RECALIBRATED THE ASSAY AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 17.9 NG/ML. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL VITAMIN D RESULT OF 10.2 NG/ML. THE CUSTOMER RECALIBRATED THE ASSAY AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 15.4 NG/ML. ON (B)(6) 2024, SAMPLE 3 HAD AN INITIAL VITAMIN D RESULT OF 8.7 NG/ML. THE CUSTOMER RECALIBRATED THE ASSAY AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 13.5 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978770 ↗