Atellica CH uALB_2 11097610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414596310), received between Nov 30, 2023 and Nov 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

1 FDA recall record name this device's identifier, 1 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 15, 2024Class IIOpen, Classified

   Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.

   Z-3169-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionNov 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED MICROALBUMIN_2 (ALB_2) 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 RETESTED MULTIPLE TIMES WITH AND WITHOUT DILUTIONS ON THE ORIGINAL ANALYZER AS PART OF TROUBLESHOOTING. THEN, THE SAMPLE WAS REPEATED WITH 1:100 MANUAL DILUTION ON THE ORIGINAL ANALYZER AND A HIGHER RESULT WAS OBTAINED. THE HIGHER REPEAT RESULT WAS 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 ALB_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630238 ↗
• MalfunctionDec 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED MICROALBUMIN_2 (ALB_2) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE HIGHER REPROCESSED 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 ERRONEOUSLY DEPRESSED MICROALBUMIN_2 (ALB_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025015 ↗
• MalfunctionNov 30, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED MICROALBUMIN 2 (ALB 2) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA ®CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. THE HIGHER REPROCESSED RESULT OBTAINED WAS 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 MICROALBUMIN 2 (ALB 2) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236122 ↗