ADVIA Centaur® Active B12 10995088Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414603100), received between Oct 16, 2018 and Oct 16, 2018 — classified as 1 malfunction.

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.

• MalfunctionOct 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER OBSERVED THE REAGENT IS NOT HOMOGENOUS, PARTICLES/SEDIMENT CAN BE SEEN IN THE BOTTOM OF THE REAGENT READYPACK FOR LOT 32689016. THE INITIAL TESTING WAS ON (B)(6) 2018 AND THE REPEAT TESTING WAS ON (B)(6) 2018. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE AB12 DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7970421 ↗