Atellica IM CEA 10995523Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00630414598505), received between Oct 10, 2019 and Jun 5, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHEN USING REAGENT LOT#: 222, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON ALTERNATE ANALYZERS. AN INITIAL ELEVATED CEA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL ATELLICA IM ANALYZER, AND THE REPEAT RESULTS RECOVERED LOWER BUT WERE OVER THE REFERENCE RANGE. THE SAME SAMPLE WAS REPROCESSED AGAIN WITH HETEROPHILIC BLOCKING TUBE (HBT) TESTING ON AN ALTERNATE ATELLICA IM ANALYZER (S/N: (B)(6) AND OBTAINED AN ELEVATED RESULT EQUIVALENT TO THE INITIAL ERRONEOUS RESULT. THE SAMPLE WAS THEN REPEATED ON AN ALTERNATE TEST METHOD (ROCHE ANALYZER) AND OBTAINED A LOWER RESULT RECOVERED WITHIN THE REFERENCE RANGE, WHICH WAS CONSIDERED CORRECT, AND ALL THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLE WAS MANUALLY DILUTED FIVE TIMES AND AGAIN TESTED ON AN UNKNOWN ANALYZER, AND THE FIFTH REPEAT RESULT RECOVERED LOWER BUT WAS OVER THE REFERENCE RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148200 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED RESULTS ON A PATIENT SAMPLE USING ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA) LOT 222. THE RESULTS WERE DISCORDANT RELATIVE TO A LOWER RETEST RESULT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085343 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED PATIENT SAMPLE RESULT WITH ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA) LOT 222 THAT WAS DISCORDANT RELATIVE TO A LOWER RETEST RESULT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085342 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED PATIENT SAMPLE RESULT WITH ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA) LOT 222 THAT WAS DISCORDANT RELATIVE TO A LOWER RETEST RESULT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085341 ↗
• MalfunctionApr 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING CEA LOT 223. AN INITIAL ATELLICA IM CEA RESULT DISAGREED WITH LOWER RESULTS OBTAINED IN REPEAT TESTING USING BOTH THE INITIAL INSTRUMENT AND AN ALTERNATE ATELLICA IM ANALYZER. 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 21750842 ↗
• MalfunctionJan 11, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A DISCORDANT, ELEVATED ATELLICA IM CARCINOEMRYOINIC (CEA) RESULT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED TWICE AND RESULTS WERE LOWER. ONE OF THE RETEST RESULTS WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146363 ↗
• MalfunctionJan 7, 2021High Test Results; High Test Results

  A CUSTOMER OBTAINED AN INITIAL DISCORDANT HIGH ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) PATIENT SAMPLE RESULT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. PER CUSTOMER PROTOCOL, THE SAMPLE WAS SENT TO ANOTHER TESTING SITE (PLS AA1). THE SAME SAMPLE WAS ALSO REPEATED AT THE CUSTOMER SITE (PLS MEH) 2 DAYS LATER. BOTH REPEAT RESULTS WERE LOWER THAN THE INITIAL DISCORDANT RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL DISCORDANT CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133867 ↗
• MalfunctionAug 11, 2020Low Test Results; Low Test Results

  CUSTOMER OBSERVED MULTIPLE ATELLICA IM 1300 CARCINOEMBRYONIC ANTIGEN (CEA) LOW RESULTS FOR THE SAME PATIENT (MULTIPLE DRAWS) AS COMPARED TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOWER ATELLICA IM 1300 CEA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394265 ↗
• MalfunctionAug 11, 2020Low Test Results; Low Test Results

  CUSTOMER OBSERVED MULTIPLE ATELLICA IM 1300 CARCINOEMBRYONIC ANTIGEN (CEA) LOW RESULTS FOR THE SAME PATIENT (MULTIPLE DRAWS) AS COMPARED TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOWER ATELLICA IM 1300 CEA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394264 ↗
• MalfunctionAug 11, 2020Low Test Results; Low Test Results

  CUSTOMER OBSERVED MULTIPLE ATELLICA IM 1300 CARCINOEMBRYONIC ANTIGEN (CEA) LOW RESULTS FOR THE SAME PATIENT (MULTIPLE DRAWS) AS COMPARED TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOWER ATELLICA IM 1300 CEA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394260 ↗
• MalfunctionOct 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED A DISCORDANT CEA RESULT ON THE ATELLICA IM 1300 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE CUSTOMER INDICATED THAT QUALITY CONTROL (QC) WAS FOUND TO BE OUTSIDE OF THE LABORATORY'S ACCEPTABLE RANGE ON 9/17/2019 ON ONE ATELLICA IM 1300 ANALYZER (IM00745). QC WAS REPEATED AND WHEN CONFIRMED TO BE IN RANGE CEA SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. DISCORDANCE WAS FOUND BETWEEN THE INITIAL RESULT AND REPEAT RESULT ON ONE OF THESE SAMPLES. THE DISCORDANT SAMPLE WAS REPEATED AGAIN ON A DIFFERENT ATELLICA IM 1300 ANALYZER (IM00746) AND RESULT WAS SIMILAR TO THE FIRST REPEAT RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULT.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 9176997 ↗