ADVIA Centaur® VB12 10309970Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414177168), received between Dec 14, 2017 and Nov 8, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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.

• MalfunctionNov 8, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCORDANT ELEVATED ADVIA CENTAUR VITAMIN B12 SAMPLE RESULTS ON MULTIPLE PATIENTS. ON REPEAT TESTING THE SAMPLES WITH AN ALTERNATE METHOD, THE RESULTS WERE LOWER. THE INITIAL RESULTS WERE REPORTED TO PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT VITAMIN B12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751240 ↗
• MalfunctionJul 30, 2020High Test Results; High Test Results

  A CUSTOMER OBTAINED DISCORDANT RESULTS FOR (2) PATIENT SAMPLES TESTED USING THE ADVIA CENTAUR XPT VITAMIN B12 (VB12) ASSAY. THE CUSTOMER INFORMED SIEMENS THAT THEY ARE TESTING PATIENTS SAMPLES FOR VITAMIN B12 IN DUPLICATE (1 REPLICATE IS TESTED ON 2 DIFFERENT ADVIA CENTAUR XPT SYSTEMS). IT IS UNKNOWN WHICH RESULT IS CONSIDERED THE CORRECT RESULT. THERE WAS NO REPORT OF ALTERED PATIENT TREATMENT BASED ON THE DISCORDANT VB12 RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10347415 ↗
• MalfunctionJun 26, 2020High Test Results; High Test Results

  A CUSTOMER OBTAINED A FALSELY ELEVATED RESULT ON A PATIENT SAMPLE USING ADVIA CENTAUR XPT VITAMIN B12 (VB12). QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED AT THE REQUEST OF THE PHYSICIAN. THE SAMPLE WAS REFRIGERATED AND REPEAT TESTING WAS PERFORMED ON THE REFRIGERATED SAMPLE, AT ROOM TEMPERATURE AND RE-CENTRIFUGED. THE SAME INSTRUMENT WAS USED FOR THE REPEAT TESTING. LOWER RESULTS WERE OBTAINED FOR THESE 3 CONDITIONS. A CORRECTED REPORT ISSUED, BUT IT IS UNKNOWN IF ALL 3 REPEAT RESULTS WERE PROVIDED IN THE CORRECTED REPORT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED BASED ON THE DISCORDANT VB12 RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10204145 ↗
• MalfunctionJun 26, 2020High Test Results; High Test Results

  A CUSTOMER OBTAINED A FALSELY ELEVATED RESULT ON A PATIENT SAMPLE USING ADVIA CENTAUR XPT VITAMIN B12 (VB12). QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED AT THE REQUEST OF THE PHYSICIAN. THE SAMPLE WAS REFRIGERATED AND REPEAT TESTING WAS PERFORMED ON THE REFRIGERATED SAMPLE, AT ROOM TEMPERATURE AND RE-CENTRIFUGED. THE SAME INSTRUMENT WAS USED FOR THE REPEAT TESTING. LOWER RESULTS WERE OBTAINED FOR THESE 3 CONDITIONS. A CORRECTED REPORT ISSUED, BUT IT IS UNKNOWN IF ALL 3 REPEAT RESULTS WERE PROVIDED IN THE CORRECTED REPORT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED BASED ON THE DISCORDANT VB12 RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10204143 ↗
• MalfunctionDec 13, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IN A CASE REPORT FROM 2012, THE ADVIA CENTAUR VB12 ASSAY WAS REPORTED TO SHOW NORMAL RESULTS THAT WERE DISCORDANT WITH THE CLINICAL PICTURE OF THE PATIENT. THE PATIENT'S CLINICAL APPEARANCE IS ONE OF B12 DEFICIENCY. THE (B)(6)-YEAR OLD WOMAN WITH SEVERE ANAEMIA (HAEMOGLOBIN 58 G/L) WHO HAD BEEN SUFFERING FROM PROGRESSIVELY INCREASING PALPITATIONS, PROFOUND FATIGUE AND EXERTIONAL DYSPNOEA FOR ABOUT ONE MONTH WAS ADMITTED TO THE HOSPITAL IN (B)(6) 2011. THE VITAMIN B12 AND FOLATE DEFICIENCY WERE CONSIDERED IMMEDIATELY. HOWEVER, THE RESULTS WERE IN THE NORMAL RANGE. THE PATIENT RECEIVED TWO RED CELL UNITS AND WAS DISCHARGED FROM THE HOSPITAL. TWO WEEKS LATER, THE PATIENT WAS ADMITTED AGAIN WITH ANEMIA BASED ON HEMOGLOBIN LEVELS, AND WHEN TESTED FOR VITAMIN B12 LEVELS THE RESULTS WERE IN THE NORMAL RANGE. IT WAS DECIDED AT THIS POINT TO TREAT THE PATIENT WITH A PHARMACOLOGICAL DOSE OF SUBCUTANEOUS VITAMIN B12. AFTER 2 WEEKS, THE PATIENT'S CONDITION IMPROVED AND COMPLETE CLINICAL AND HAEMATOLOGICAL RECOVERY OCCURRED WITHIN THE NEXT MONTH. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULTS WITH THE CLINICAL PICTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162181 ↗
• MalfunctionJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS WERE OBTAINED ON SAMPLES FROM TWO PATIENTS DURING TROUBLESHOOTING. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VB12 DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650011 ↗
• MalfunctionMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS WERE OBTAINED ON A PATIENT SAMPLE DURING TROUBLESHOOTING. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VB12 DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7508928 ↗
• MalfunctionDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR XPT VB12 (VITAMIN B12) RESULTS WERE OBTAINED ON SAMPLES FROM TWO PATIENTS. THE RESULTS WERE DISCORDANT WITH THE IMMULITE 2000 XPI PLATFORM. THE CUSTOMER RAN THE PATIENT SAMPLES ON THE SAME INSTRUMENTS AND SAME RUN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VB12 DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7116945 ↗