Atellica IM CEA 10995524Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414598512), received between Apr 4, 2022 and Jan 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING CEA LOT 226. THE CUSTOMER INDICATES THAT SOME SAMPLES HAVE PRODUCED FALSELY-DEPRESSED ATELLICA IM CEA RESULTS WHICH DISAGREED WITH HIGHER RESULTS PRODUCED UPON REPEAT TESTING USING THE SAME INSTRUMENT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE DISCORDANT OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162041 ↗
• MalfunctionMay 16, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. CEA LOT 218 WAS IN USE AT THE TIME. ELEVATED RESULTS WERE OBSERVED FOR 18 PATIENTS. THE RESULTS WERE VERY HIGH, AND WERE NOT REPORTED TO PHYSICIANS. THE SAME SAMPLES WERE REPEAT-TESTED USING ANOTHER REAGENT PACK FROM THE SAME LOT, AND ALL OF THE RESULTS WERE MUCH LOWER. THESE LOWER RESULTS WERE CONSISTENT WITH CLINICAL EXPECTATION, AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333287 ↗
• MalfunctionApr 4, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DISCORDANT FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR A PATIENT SAMPLE ON AN ATELLICA IM ANALYZER (B)(4) WHEN COMPARED TO A PREVIOUS HIGHER RESULT FROM (B)(6) 2022. THE PATIENT SAMPLE WAS REPEATED ON THE ORIGINAL AND ALTERNATE (B)(4) ATELLICA IM ANALYZERS. THE RESULTS FROM THE ORIGINAL ATELLICA IM ANALYZER SHOWED DISCORDANCY BETWEEN RESULTS. THE RESULT FROM THE ALTERNATE ATELLICA IM ANALYZER WAS HIGHER THAN THE INITIAL DEPRESSED RESULT AND SIMILAR TO THE PREVIOUS RESULT FROM (B)(6) 2022. THE INITIAL CEA RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002764 ↗