Atellica CI Analyzer 10947347Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414229553), received between May 15, 2024 and Sep 11, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K222116); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740699 ↗
• MalfunctionJun 8, 2026High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). IT IS UNKNOWN WHETHER THERE WERE ANY KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THIS EVENT, HOWEVER, NO HARM OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT WERE ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425257 ↗
• MalfunctionJun 3, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED TOTAL HCG (THCG) PATIENT SAMPLE RESULT WAS OBTAINED WHEN PROCESSED ON AN ATELLICA CI 1900 ANALYZER (S/N: (B)(6). AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS THEN REPROCESSED ON AN ALTERNATE ATELLICA CI 1900 ANALYZER, WHICH PRODUCED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AS IT WAS CONSISTENT WITH THE CLINICAL PICTURE OF THE PATIENT, AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374168 ↗
• MalfunctionMay 7, 2026High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED SODIUM (NA) RESULTS ON TWO SAMPLES FROM THE PATIENT ON THE ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULTS AND MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED NA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110019 ↗
• MalfunctionApr 10, 2026Sparking

  THE CUSTOMER REPORTED A BURNING SMELL, AND SPARKS WERE COMING FROM THE BOXES AT THE BACK OF AN ATELLICA CI 1900 ANALYZER. THE POWER BLOCK CONNECTION TO THE MONITOR WAS LOOSE, CAUSING HEAT AND SPARKS. THERE WAS NO INJURY, AND NO VISIBLE FLAME OR SMOKE DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842234 ↗
• MalfunctionMar 6, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY LOW CALCIUM (CA_2) TEST RESULT WAS OBTAINED FROM AN ATELLICA CI ANALYZER. THE INITIAL TEST RESULT WAS RELEASED TO A PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED TWICE ON THE SAME ANALYZER. THE REPEAT RESULTS WERE HIGHER AND RELEASED TO A PHYSICIAN AS THE CORRECT TEST RESULTS. THE CUSTOMER INDICATED THERE WERE NO ERROR FLAGS ON THE TEST RESULTS. 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 24533877 ↗
• MalfunctionMay 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED CONCENTRATE CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPEAT RESULT MATCHED THE PATIENT'S CLINICAL HISTORY AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975044 ↗
• MalfunctionApr 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON 7 PATIENT SAMPLES ON AN ATELLICA CI ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME ATELLICA CI ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876167 ↗
• MalfunctionNov 7, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ORIGINAL ATELLICA CI 1900 ANALYZER. THE REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL RESULT AND WERE CONSIDERED CORRECT. IT IS UNKNOWN WHICH REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630249 ↗
• MalfunctionNov 6, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM (NA) TEST RESULTS WERE OBTAINED ON NINE PATIENT SAMPLES FROM AN ATELLICA CI ANALYZER AND STATED THAT THE RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING USING THE SAME SAMPLES ON A DIMENSION VISTA ANALYZER AT THEIR SISTER SITE AND NOTED THAT THE REPEAT RESULTS WERE CONSIDERED CORRECT, AND THE CUSTOMER ISSUED A CORRECTED REPORT. AFTER NOTICING THE SHIFT IN CONSECUTIVE PATIENT RESULTS, THE CUSTOMER STATED THEY RAN QUALITY CONTROL MATERIALS FOR SODIUM, POTASSIUM AND CHLORIDE AND OBTAINED RESULTS THAT EXCEEDED THE ASSAY RANGE, SO THEY STOPPED REPORTING SODIUM, POTASSIUM AND CHLORIDE. 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 20622874 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND MATCHED THE PATIENT¿S CLINICAL PRESENTATION AND HISTORY. THE REPEAT RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343293 ↗
• MalfunctionMay 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321410 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222116. One submission often covers many models, so check the product and lot details in each record.

• Z-0597-2025 · Nov 4, 2024 · Open, Classified
  Atellica CI Analyzer. Catalog Numbers: 10947347.