Atellica CH UCFP 11097543Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00630414279206), received between Mar 10, 2023 and Jul 31, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (19 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 11, 2025Class IIOpen, Classified

   Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

   Z-2542-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 29, 2024Class IIOpen, Classified

   The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

   Z-3063-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097973 ↗
• MalfunctionOct 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON ONE (1) PATIENT SAMPLE ON THE ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279025 ↗
• MalfunctionOct 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS REGARDING ONE (1) ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULT OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410112 ↗
• MalfunctionJun 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON FOUR (4) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT (S/N (B)(6) ). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 INSTRUMENT (S/N (B)(6) ). THE REPROCESSED HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605916 ↗
• MalfunctionJun 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 INSTRUMENT S/N (B)(6). THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE INITIAL ATELLICA CH 930 INSTRUMENT WITH AN ALTERNATE REAGENT LOT. A HIGHER REPROCESSED RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549865 ↗
• MalfunctionJun 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT (S/N (B)(6)). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE INITIAL ATELLICA CH 930 INSTRUMENT WITH AN ALTERNATE REAGENT LOT. THE REPROCESSED SAMPLES OBTAINED HIGHER UCFP RESULTS THAT WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549052 ↗
• MalfunctionJun 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT S/N (B)(6). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE INITIAL ATELLICA CH 930 INSTRUMENT WITH AN ALTERNATE REAGENT LOT. THE REPROCESSED SAMPLES OBTAINED HIGHER UCFP RESULTS THAT WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548469 ↗
• MalfunctionMay 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A DISCORDANT DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 INSTRUMENT. THE REPEAT RESULT WAS THE SAME AS THE DISCORDANT RESULT. THE PATIENT SAMPLE WAS REPEATED ON AN ALTERNATE NON-SIEMENS METHOD AT AN ALTERNATE SITE AND THE RESULT WAS HIGHER. THE CUSTOMER IS NOT SURE WHICH RESULT IS CORRECT AND SENT BOTH RESULTS TO THE PHYSICIAN WITHOUT ISSUING A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED UCFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232474 ↗
• MalfunctionApr 1, 2024Low Test Results; Low Test Results

  FIVE (5) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND UNKNOWN IF QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA ® CH 930 ANALYZER UTILIZING AN ALTERNATE REAGENT LOT. THE REPEATED SAMPLE RESULTS WITH THE ALTERNATE REAGENT LOT WERE CONSIDERED CORRECT AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010412 ↗
• MalfunctionMar 13, 2024Low Test Results; Low Test Results

  TWO (2) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894622 ↗
• MalfunctionMar 11, 2024Low Test Results; Low Test Results

  FIVE (5) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN, AND IT IS UNKNOWN IF THEY WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON ALTERNATE ATELLICA ® CH 930 ANALYZERS. THE HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874951 ↗
• MalfunctionMar 8, 2024Low Test Results; Low Test Results

  SIX (6) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. THE HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864569 ↗
• MalfunctionFeb 6, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649120 ↗
• MalfunctionOct 23, 2023Low Test Results; Low Test Results

  TWO (2) DISCORDANT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER WITH 1:10 DILUTION AND OBTAINED A FALSELY DEPRESSED RESULT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. A HIGHER RESULT CONSIDERED CORRECT WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986451 ↗
• MalfunctionAug 30, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT RESULT WAS OBTAINED ON AN ATELLICA® CH 930 ANALYZER. CUSTOMER STATED THE URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) IS INACCURATE, FALSELY DEPRESSED AND INCONSISTENT WITH THE MICROALBUMIN_2 (ALB_2) RESULT. THE FALSELY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS NOT REPROCESSED. CUSTOMER STATED THEY DO NOT KNOW THE CORRECT RESULT BECAUSE THERE IS NO UCFP REAGENT FROM OTHER MANUFACTURERS TO COMPARE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651910 ↗
• MalfunctionAug 14, 2023Low Test Results; Low Test Results

  ONE (1) FALSELY DEPRESSED URINE PATIENT SAMPLE RESULT WAS OBTAINED WITH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP, LOT NUMBER 120243) WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER (S/N: (B)(6)). THE RESULT WAS DEPRESSED COMPARED TO THE ATELLICA CH MICROALBUMIN (UALB_2) RESULT AND A RESULT FROM A ROUTINE URINE TEST METHOD. THE INITIAL UCFP RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED UCFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546065 ↗
• MalfunctionAug 11, 2023Low Test Results; Low Test Results

  THE CUSTOMER INFORMED SIEMENS OF DISCORDANT LOW ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP), LOT 120243 RESULTS ON A URINE SAMPLE. THE RETEST RESULT ON AN ALTERNATE METHOD WAS HIGHER. THE DISCORDANT RESULTS WERE NOT REPORTED. THE SAMPLE WAS RETESTED USING AN ALTERNATE UCFP METHOD AND THE RESULT WAS REPORTED AS CORRECT AND NOT QUESTIONED BY THE PHYSICIAN. QC WERE ALL WITHIN THE NORMAL RANGES. THE PATIENT HAS TYPE 2 DIABETES, MEDICATION IS UNKNOWN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509507 ↗
• MalfunctionJun 19, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS ON TWO PATIENT SAMPLES FROM AN ATELLICA CH 930 ANALYZER. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE TESTING PLATFORM. THE REPEAT RESULTS WERE HIGHER THAN THE FALSELY DEPRESSED RESULTS. THE REPEAT RESULTS WERE REPORTED AS CORRECT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED UCFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151331 ↗
• MalfunctionMar 10, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) URINE SAMPLE RESULT USING LOT 120243 ON AN ATELLICA CH ANALYZER THAT DID NOT MATCH WITH THE PROFILE OF THE OTHER TESTS PERFORMED ON THIS PATIENT. A RETEST WAS PERFORMED ON THE SAME SAMPLE AND ANALYZER AND THE RESULT WAS SIMILAR TO THE INITIAL RESULT. THE ATELLICA CH UCFP RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS ALSO PROCESSED ON ATELLICA CH ANALYZERS WITH OPEN CHANNEL NON-SIEMENS URINE TOTAL PROTEIN REAGENT. THE CUSTOMER CONSIDERED THESE RESULTS TO BE FALSELY DEPRESSED AS WELL. RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT UCFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523611 ↗