Atellica CH Acet 11097522Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414595894), received between Jan 13, 2021 and Apr 28, 2026 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K100200); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THREE ERRONEOUSLY DEPRESSED ACETAMINOPHEN (ACET) RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 25023752 ↗
• MalfunctionApr 28, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THREE ERRONEOUSLY DEPRESSED ACETAMINOPHEN (ACET) RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 25023748 ↗
• MalfunctionJan 13, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW ACETAMINOPHEN RESULT WAS OBTAINED A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH ACETAMINOPHEN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR ACETAMINOPHEN ON TWO NON-SIEMENS ANALYZERS, RESULTING HIGHER. THE HIGHER RESULT OBTAINED ON THE FIRST NON-SIEMENS ANALYZER WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACETAMINOPHEN RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11158572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100200. One submission often covers many models, so check the product and lot details in each record.

• Z-2416-2015 · Jun 30, 2015 · Terminated
  ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistr