Elecsys Vitamin D total II 07464215160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613336129197), received between Jul 30, 2018 and Aug 22, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE VITAMIN D TOTAL G2 ELECSYS AND VITAMIN D TOTAL G3 ELECSYS RESULTS FOR 14 PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE WITH SERIAL NUMBER (B)(4). THE REPORTER IS QUESTIONING VITAMIN D V3 RESULTS COMPARED TO VITAMIN D V2 PATIENT RESULTS. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES OF PATIENTS 27, 29, 35 AND 37 WERE RERUN ON THE MODULE AND A SIEMEN'S INTELLICA. PATIENT 4 HAD AN INITIAL VITAMIN D V3 RESULT OF >120 NG/ML WITH A DATA FLAG. THE VITAMIN D V2 REPEAT RESULT WAS 77.6 NG/ML. PATIENT 5 HAD AN INITIAL VITAMIN D V3 RESULT OF 76 NG/ML. THE VITAMIN D V2 REPEAT RESULT WAS 48.5 NG/ML. PATIENT 10 HAD AN INITIAL VITAMIN D V3 RESULT OF 91.8 NG/ML. THE VITAMIN D V2 REPEAT RESULT WAS 51.8 NG/ML. PATIENT 13 HAD AN INITIAL VITAMIN D V3 RESULT OF >120 NG/ML WITH A DATA FLAG. THE VITAMIN D V2 REPEAT RESULT WAS 76.2 NG/ML. PATIENT 16 HAD AN INITIAL VITAMIN D V3 RESULT OF 62.7 NG/ML. THE VITAMIN D V2 REPEAT RESULT WAS 40.6 NG/ML. PATIENT 22 HAD AN INITIAL VITAMIN D V3 RESULT OF 67.2 NG/ML. THE VITAMIN D V2 REPEAT RESULT WAS 34.1 NG/ML. PATIENT 27 HAD AN INITIAL VITAMIN D V3 RESULT OF 117.7 NG/ML. THE VITAMIN D V2 FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266742 ↗
• MalfunctionAug 6, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE HIGH VITAMIN D TOTAL GEN 2 RESULTS FOR ONE PATIENT SAMPLE FROM TWO COBAS 8000 COBAS E 602 MODULES. THE INITIAL RESULT WAS >100 NG/ML WITH A DATA FLAG FROM COBAS E602 SERIAL NUMBER (B)(4). THE REPEAT RESULT ON (B)(6) 2018 WAS 110 NG/ML FROM COBAS E602 SERIAL NUMBER (B)(4). THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED WITH A DILUTION AND THE RESULTS WERE 155.9 NG/ML AND 145.22 NG/ML. THE COBAS E602 ANALYZER USED FOR THIS TESTING WAS NOT PROVIDED. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS 55 NG/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FIELD SERVICE REPRESENTATIVE VERIFIED THE ANALYZER PERFORMED WITHIN SPECIFICATION. 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 MEASUREMENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7751557 ↗
• MalfunctionJul 30, 2018Low Test Results; Low Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS VITAMIN D GEN 2 ASSAY RESULTS FOR QC MATERIAL AND AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM 06-JUL-2018 THROUGH 11-JUL-2018 FROM COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). OF THE DATA PROVIDED FOR EIGHT PATIENT SAMPLES TESTED ON (B)(6) 2018, ONLY THE DATA FOR ONE PATIENT SAMPLE WAS DISCREPANT. THE INITIAL RESULT WAS 39.39 NG/ML AND THE REPEAT RESULT WAS 82.83 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER FOLLOWED UP WITH THE PHYSICIANS AND PROVIDED THE CORRECTED RESULT. THERE WAS NO ADVERSE EVENT. THE CUSTOMER BELIEVED THERE WAS A REAGENT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730834 ↗

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