ADVIA CHEM Ecre3 11537235Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Creatinine enzymatic - ADVIA Chem. - RGT · 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 00630414610962), received between Nov 3, 2023 and Nov 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (2 reports).
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
- Low Test Results2
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.
MalfunctionNov 3, 2023Low Test Results; Low Test Results
A FALSELY DEPRESSED ENZYMATIC CREATININE_3 (ECRE3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT SYSTEM AND CONSIDERED DISCORDANT WHEN COMPARED TO THE OTHER REPLICATES FROM THE SAME SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED ENZYMATIC CREATININE_3 (ECRE3) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064580 ↗MalfunctionNov 3, 2023Low Test Results; Low Test Results
FALSELY DEPRESSED ENZYMATIC CREATININE_3 (ECRE3) RESULTS WERE OBTAINED ON SAMPLES FROM TWO PATIENTS ON AN ADVIA CHEMISTRY XPT SYSTEM AND CONSIDERED DISCORDANT WHEN COMPARED TO ANOTHER REPLICATE FROM THE SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED ENZYMATIC CREATININE_3 (ECRE3) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064530 ↗
Other ENZYMATIC METHOD, CREATININE devices
- CLINITEK Status®+ Analyzer 10379675Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE89 reports
- ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) 10335869Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall24 reports
- Dimension Vista® Flex® reagent cartridge ECREA 10700444Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall10 reports
- Atellica CH ECre_2 11097533Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall6 reports
- VITROS 6802584Ortho-Clinical Diagnostics, Inc. · ENZYMATIC METHOD, CREATININE52 reports
- Dimension® Flex® reagent cartridge EZCR 10471520Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall1 report
- Afinion HbA1c 1116974Abbott Diagnostics Technologies AS · Enzymatic Method, Creatinine1 recall0 reports
- Creatinine plus ver2 5168589190Roche Diagnostics GmbH · ENZYMATIC METHOD, CREATININE27 reports
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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