Atellica CH VPA 11097512Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Valproic Acid (VPA) Atellica CH - RGT 400T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414596013), received between Mar 4, 2024 and Mar 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024High Test Results; High Test Results
A DISCORDANT FALSELY ELEVATED VALPROIC ACID (VPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN THE SAMPLE WAS REPROCESSED ON AN ATELLICA CH 930 ANALYZER. THE FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE INITIAL LOW RESULT OBTAINED FOR THE SAME SAMPLE ON THE PREVIOUS DAY WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED VALPROIC ACID (VPA) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18824925 ↗MalfunctionMar 4, 2024Low Test Results; Low Test Results
DISCORDANT FALSELY DEPRESSED VALPROIC ACID (VPA) RESULTS WERE OBTAINED ON SIX (6) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). TWO (2) SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE OTHER FOUR (4) SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED VALPROIC ACID (VPA) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18824920 ↗
Other ENZYME IMMUNOASSAY, VALPROIC ACID devices
- VITROS 6801710Ortho-Clinical Diagnostics, Inc. · ENZYME IMMUNOASSAY, VALPROIC ACID1 recall23 reports
- Valproic Acid 4491041190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, VALPROIC ACID3 reports
- Dimension® Flex® reagent cartridge VALP 10444943Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, VALPROIC ACID3 reports
- Valproic Acid 5108438190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, VALPROIC ACID2 reports
- Valproic Acid 20737933322Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, VALPROIC ACID1 report
- IMMULITE® 2000 Systems VAL Valproic Acid 10381544Siemens Healthcare Diagnostics Products Ltd · ENZYME IMMUNOASSAY, VALPROIC ACID1 report
- Syva® Emit® 2000 Valproic Acid Assay 10445312Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, VALPROIC ACID1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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