IMMULITE® 2000 Systems VB Vitamin B12 10380914Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414962313), received between Dec 13, 2018 and Dec 13, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K993251); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2018High Test Results; High Test Results

  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) 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 8162095 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993251. One submission often covers many models, so check the product and lot details in each record.

• Z-0537-05 · Jan 24, 2005 · Terminated
  IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.