Atellica CH Urine Albumin (UAlb) 11537225Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414611099), received between Feb 3, 2026 and Feb 19, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (8 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. Jul 6, 2026Class IIOpen, Classified

   processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

   Z-2890-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 20, 2026Class IIOpen, Classified

   Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

   Z-1484-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AFTER PROCESSING A PATIENT SAMPLE FOR URINE ALBUMIN (UALB) ON A ATELLICA CH 930 ANALYZER, PREVIOUS RESULTS FOR THE SAME PATIENT WERE QUESTIONED. THE CUSTOMER BELIEVES THE RESULTS OBTAINED ON THE PATIENT SAMPLE FROM (B)(6) 2026 TO BE CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT URINE ALBUMIN (UALB) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392920 ↗
• MalfunctionFeb 18, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) PATIENT SAMPLE RESULT WHEN THE SAMPLE WAS DILUTED ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS HIGHER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CI 1900 ANALYZER MULTIPLE TIMES WITH A 1:5 DILUTION. HIGHER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. THE INITIAL HIGHER 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 ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378076 ↗
• MalfunctionFeb 12, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE 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 URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323281 ↗
• MalfunctionFeb 9, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE RESULT OBTAINED WAS CONSIDERED ERRONEOUS. THE SAME SAMPLE WAS REPROCESSED DILUTED (1:10) ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A HIGHER RESULT WAS OBTAINED CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296915 ↗
• MalfunctionFeb 9, 2026Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED DILUTED (1:10) ON THE SAME 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 URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289259 ↗
• MalfunctionFeb 9, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED ON THE SAME 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 URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289234 ↗
• MalfunctionFeb 4, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED DILUTED (1:10) ON THE SAME 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 ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257485 ↗
• MalfunctionFeb 3, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED MANUALLY DILUTED (1:5) AND AUTO DILUTED (1:10) ON THE SAME ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND ONE RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245407 ↗