Atellica IM AB12 10733001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414245720), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.

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

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.

• MalfunctionJan 8, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING AB12 LOT 104. AN INITIAL AB12 RESULT WITHIN NORMAL RANGE WAS OBTAINED FOR THE PATIENT IN QUESTION, BUT WAS CONSIDERED INCONSISTENT WITH PATIENT MEDICAL HISTORY. THE SAME SAMPLE WAS RE-TESTED THE NEXT DAY, PRODUCING A MUCH LOWER RESULT (BELOW REFERENCE RANGE). THE PATIENT RESULT WAS CORRECTED AND THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THE SAMPLE WAS ALSO RE-TESTED ON ANOTHER ATELLICA IM ANALYZER, AND IT PRODUCED A SIMILAR LOW RESULT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. NO ISSUES WERE IDENTIFIED WITH ASSAY QUALITY CONTROL (QC) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002144 ↗