Elecsys Vitamin D total II 07028148190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630940127), received between Jul 31, 2018 and Dec 10, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K162840); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF QC ISSUES WITH A PARTICULAR REAGENT LOT FOR ELECSYS VITAMIN D TOTAL II (VITAMIN D TOTAL II) OCCURRING SINCE (B)(6) 2024. THERE WAS AN ALLEGATION OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR VITAMIN D TOTAL II ON A COBAS E801 ANALYZER. THE INITIAL RESULT WAS 71.3 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR INDICATED THE RESULT DID NOT MATCH THE PATIENT¿S CLINICAL CONDITION. THE SAMPLE WAS REPEATED ON A DIFFERENT E801 ANALYZER WITH A RESULT OF 23.0 NG/ML. ON (B)(6) 2024 THE ORIGINAL SAMPLE WAS REPEATED ON THE E801 ANALYZER IN QUESTION WITH A RESULT OF 20.2 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892389 ↗
• MalfunctionNov 13, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN D TOTAL II (VITAMIN D TOTAL II) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS >100 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 17.5 NG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674438 ↗
• MalfunctionJun 7, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN D TOTAL II RESULTS FOR TWO PATIENTS TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSES ALERTING THE REPORTER TO AN ISSUE WITH THE RESULTS. SAMPLE (B)(6) . THE INITIAL RESULT WAS 250 NMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 38.9 NMOL/L. THE SECOND REPEAT RESULT WAS 38.1 NMOL/L. SAMPLE (B)(6) . THE INITIAL RESULT WAS >250 NMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 70.1 NMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481658 ↗
• MalfunctionDec 27, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2022, THE INITIAL VITAMIN D RESULT WAS 100 NG/ML WITH FLAG. ON (B)(6) 2022, THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 11.2 NG/ML AND 20.8 NG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 601999 AND THE EXPIRATION DATE IS 28-FEB-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052740 ↗
• MalfunctionAug 8, 2022Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS VITAMIN D TOTAL GEN. 2 ASSAY (VITD2) ON A COBAS 8000 E 801 MODULE. THE CUSTOMER WAS PERFORMING A METHOD COMPARISON STUDY BETWEEN THE VITD2 ASSAY AND THE ELECSYS VITAMIN D TOTAL GEN. 3 ASSAY (VITD3) AND VALUES MEASURED WITH TWO PATIENT SAMPLES DID NOT AGREE. ONLY THE VALUES FROM THE VITD2 ASSAY WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT KNOW WHICH VALUES WERE CORRECT. THE PRIMARY TUBE OF THE FIRST SAMPLE RESULTED IN A VITD2 VALUE OF 114 NG/ML AND A VITD3 VALUE OF 28.9 NG/ML. THE SECONDARY TUBE OF THE FIRS SAMPLE RESULTED IN A VITD2 VALUE OF 109 NG/ML AND A VITD3 VALUE OF 30.5 NG/ML. THE SECOND PATIENT SAMPLE WAS DILUTED PRIOR TO MEASUREMENT. THE PRIMARY TUBE OF THE SECOND SAMPLE RESULTED IN A VITD2 VALUE OF 142 NG/ML AND A VITD3 VALUE OF 18.3 NG/ML. THE SECONDARY TUBE OF THE SECOND SAMPLE RESULTED IN A VITD2 VALUE OF 137 NG/ML AND A VITD3 VALUE OF 19.3 NG/ML. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183880 ↗
• MalfunctionApr 4, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN D TOTAL II RESULTS FOR 20 PATIENTS TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). PRIOR TO AND AFTER THE EVENT, THE CUSTOMER STATED THE QC RESULTS WERE ACCEPTABLE. THE CUSTOMER REPORTED THE QUESTIONABLE RESULTS WERE MEASURED WITHIN A "1-2" MINUTE TIME FRAME. THE INITIAL VITAMIN D RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLES ON A DIFFERENT E 801 MODULE. BELOW ARE FIVE EXAMPLES OF QUESTIONABLE VITAMIN D RESULTS: PATIENT 1'S INITIAL VITAMIN D RESULT WAS 9.31 NG/ML, AND THE PATIENT'S REPEAT RESULT WAS 14 NG/ML. PATIENT 2'S INITIAL VITAMIN D RESULT WAS 37.3 NG/ML, AND THE PATIENT'S REPEAT RESULT WAS 9.59 NG/ML. PATIENT 3'S INITIAL VITAMIN D RESULT WAS 34 NG/ML, AND THE PATIENT'S REPEAT RESULT WAS 9.27 NG/ML. PATIENT 4'S INITIAL VITAMIN D RESULT WAS 82.3 NG/ML, AND THE PATIENT'S REPEAT RESULT WAS 12.7 NG/ML. PATIENT 5'S INITIAL VITAMIN D RESULT WAS 38.3 NG/ML, AND THE PATIENT'S REPEAT RESULT WAS 16.1 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994327 ↗
• MalfunctionMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DAMAGED SHIP PUMP AND RETURN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869401 ↗
• MalfunctionSep 3, 2021High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS VITAMIN D TOTAL GEN. 2 ASSAY ON A COBAS 8000 E 602 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLES WERE INITIALLY TESTED USING THE VITAMIN D GEN. 2 ASSAY AND WERE FROZEN AFTER MEASUREMENT. THE SAMPLES WERE THEN THAWED TO USE AS PART OF A VALIDATION STUDY FOR THE VITAMIN D GEN. 3 ASSAY AND WERE REPEATED USING BOTH THE GEN. 2 AND GEN. 3 ASSAYS. THE MEASUREMENTS PERFORMED WITH THE FROZEN/THAWED SAMPLE WERE LOWER COMPARED TO THE INITIAL MEASUREMENTS. THE VITAMIN D GEN. 3 ASSAY OR SIMILAR DEVICE IS NOT CLEARED OR APPROVED FOR USE IN THE UNITED STATES. THE FIRST SAMPLE INITIALLY RESULTED IN A VITAMIN D GEN. 2 VALUE OF 128 AND THEN THE SAMPLE WAS FROZEN. THE SAMPLE WAS THAWED AND REPEATED USING THE GEN. 2 ASSAY, RESULTING IN A VALUES OF 91.6. THE THAWED SAMPLE WAS REPEATED USING THE GEN. 2 ASSAY ON A SECOND ANALYZER, RESULTING AS 78.6. THE THAWED SAMPLE WAS REPEATED USING THE GEN. 3 ASSAY, RESULTING IN A VALUE OF 83.9. THE SECOND SAMPLE INITIALLY RESULTED IN A VITAMIN D GEN. 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422624 ↗
• MalfunctionNov 14, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE HIGH VITAMIN D TOTAL G2 ELECSYS RESULTS FOR TWO PATIENT SAMPLES FROM COBAS E 801 MODULE SERIAL NUMBER (B)(4). PATIENT 1: THE INITIAL RESULT WAS > 100 NG/ML. THE REPEAT RESULT WAS 35.2 NG/ML. THE SAMPLE WAS RECENTRIFUGED AND TESTED IN A SAMPLE CUP WITH A RESULT OF 29.5 NG/ML. PATIENT 2: ON (B)(6) 2018, THE INITIAL RESULT WAS > 100 NG/ML. THE REPEAT RESULTS WERE 8.36 AND 8.35 NG/ML. THE SAMPLE WAS RECENTRIFUGED AND THE REPEAT RESULT WAS 8.04 NG/ML. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CALIBRATION AND QC RESULTS WERE WITHIN SPECIFICATIONS. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS® VITAMIN D TOTAL II ASSAY ¿ NON-REPRODUCIBLE FALSE HIGH RESULTS." THIS CORRECTION HAS BEEN REPORTED TO FDA. DURING THE IMPLEMENTATION OF THE ELECSYS VITAMIN D TOTAL II ASSAY ON THE MODULAR ANALYTICS E 170 MODULE, AND COBAS E 601 AND 602 SYSTEMS, THERE WERE REPORTS OF NON-REPRODUCIBLE, FALSE HIGH RESULTS. THESE CUSTOMER OBSERVATIONS WERE MADE IN COMPARISONS OF DUPLICATE MEASUREMENTS DURING ASSAY VALIDATION OF ELECSYS VITAMIN D TOTAL II ASSAY OR IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8068737 ↗
• MalfunctionOct 25, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED A QUESTIONABLE HIGH VITAMIN D TOTAL GEN 2 RESULT FOR ONE PATIENT SAMPLE FROM COBAS 6000 E601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT FROM A PLASMA SAMPLE WAS >100 NG/ML. THE SAMPLE WAS RECENTRIFUGED AND TRANSFERRED TO A SAMPLE CUP. THE REPEAT RESULT WAS 37 NG/ML. A NEW SERUM SAMPLE WAS DRAWN AND THE RESULT WAS 40 NG/ML. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS® VITAMIN D TOTAL II ASSAY ¿ NON-REPRODUCIBLE FALSE HIGH RESULTS." THIS CORRECTION HAS BEEN REPORTED TO FDA. DURING THE IMPLEMENTATION OF THE ELECSYS VITAMIN D TOTAL II ASSAY ON THE MODULAR ANALYTICS E 170 MODULE, AND COBAS E 601 AND 602 SYSTEMS, THERE WERE REPORTS OF NON-REPRODUCIBLE, FALSE HIGH RESULTS. THESE CUSTOMER OBSERVATIONS WERE MADE IN COMPARISONS OF DUPLICATE MEASUREMENTS DURING ASSAY VALIDATION OF ELECSYS VITAMIN D TOTAL II ASSAY OR IN METHOD COMPARISONS WITH ELECSYS VITAMIN D ASSAY (I.E., DURING CONVERSIONS), WHERE THE FALSELY ELEVATED DISCREPANT VALUE DID NOT FIT THE EXPECTED RESULT. THE OBSERVED ELEVATED RESULTS REPORTED W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8004131 ↗
• MalfunctionJul 31, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ELECSYS VITAMIN D GEN 2 ASSAY RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS E 801 MODULE SERIAL NUMBER (B)(4). FROM A PLASMA SAMPLE, THE INITIAL RESULT WAS 52 NG/ML AND THE REPEAT RESULT WAS 30 NG/ML. AFTER RECENTRIFUGATION, THE REPEAT RESULT WAS 24 NG/ML. A SERUM SAMPLE FROM THE PATIENT WAS TESTED AND THE RESULT WAS 24 NG/ML. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CALIBRATION AND CONTROLS RESULTS WERE WITHIN SPECIFICATIONS. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS® VITAMIN D TOTAL II ASSAY ¿ NON-REPRODUCIBLE FALSE HIGH RESULTS." THIS CORRECTION HAS BEEN REPORTED TO FDA. DURING THE IMPLEMENTATION OF THE ELECSYS VITAMIN D TOTAL II ASSAY ON THE MODULAR ANALYTICS E 170 MODULE, AND COBAS E 601 AND 602 SYSTEMS, THERE WERE REPORTS OF NON-REPRODUCIBLE, FALSE HIGH RESULTS. THESE CUSTOMER OBSERVATIONS WERE MADE IN COMPARISONS OF DUPLICATE MEASUREMENTS DURING ASSAY VALIDATION OF ELECSYS VITAMIN D TOTAL II ASSAY OR IN METHOD COMPARISONS WITH ELECSYS VITAMIN D ASSAY (

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162840. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2018 · Apr 27, 2018 · Terminated
  Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin
• Z-2390-2018 · Apr 27, 2018 · Terminated
  Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin