Atellica CH ECre_2 11097533Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414595795), received between Dec 23, 2019 and Sep 3, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 reports).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K070727); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 18, 2019Terminated

   There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

   Z-1231-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUS DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) PATIENT SAMPLE RESULT OBTAINED ON AN ATELLICA CH 930 INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED ON THE INITIAL ATELLICA CH 930 INSTRUMENT. THE REPROCESSED HIGHER RESULT OBTAINED WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129690 ↗
• MalfunctionFeb 8, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA ® CH 930 ANALYZER. THE HIGHER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669272 ↗
• MalfunctionApr 27, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT ON A MALE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER AND THE RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THIS REPEAT RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS REPEATED ON ATELLICA CH 930 ANALYZER WHICH ALSO GAVE A HIGHER RESULT COMPARED TO THE INTIAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ECRE_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823163 ↗
• MalfunctionApr 19, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT ON A FEMALE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULTS WERE CONSIDERED AS THE CORRECT RESULTS BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ECRE_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769960 ↗
• MalfunctionSep 30, 2020Low Test Results; Low Test Results

  SIEMENS INVESTIGATED THE IMPACT OF THE DRUG ETAMSYLATE ON THE ATELLICA CH ENZYMATIC CREATININE 2 (ECRE 2) ASSAY. SIEMENS PROCESSED SAMPLES AT VARYING CONCENTRATIONS (1.50 MG/DL, 3.00 MG/DL, 4.50 MG/DL, AND 6.00 MG/DL) OF ETAMSYLATE FOR ECRE 2 AND COMPARED THESE RESULTS WITH THE RESULTS OBTAINED A SAMPLE WITH NO ETAMSYLATE. SIEMENS OBSERVED THAT THE BIAS WAS GREATEST FOR THE SAMPLE WITH THE ETAMSYLATE CONCENTRATION OF 6.00 MG/DL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE BIAS OBSERVED IN ECRE 2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10606551 ↗
• MalfunctionDec 23, 2019Low Test Results; Low Test Results

  SIEMENS HEALTHCARE DIAGNOSTICS HAS BECOME AWARE OF THE POTENTIAL OF FALSELY DEPRESSED CREATININE RESULTS FOR PATIENTS UNDERGOING PHENINDIONE THERAPY WHEN USING THE ENZYMATIC METHODOLOGY. ADVIA ECRE_2 RESULTS ON A PATIENTS' SAMPLES SHOWED INTERFERENCE WITH THE PHENINDIONE DRUG AND/OR ITS METABOLITES. THE ATELLICA CH ECRE_2 ASSAY USES THE SAME REAGENTS, CALIBRATORS, AND ASSAY CONDITION AS ADVIA ECRE_2, AND IS EXPECTED TO SHOW A SIMILAR NEGATIVE INTERFERENCE IN SAMPLES FROM PATIENTS ON PHENINDIONE THERAPY. PHENINDIONE IS NOT LISTED AS AN INTERFERING SUBSTANCE IN THE ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2) INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Patient Involvement

  MAUDE report 9512754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070727. One submission often covers many models, so check the product and lot details in each record.

• Z-2283-2020 · May 4, 2020 · Terminated
  Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum,
• Z-2282-2020 · May 4, 2020 · Terminated
  ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human se
• Z-1230-2020 · Dec 18, 2019 · Terminated
  ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
• Z-1654-2016 · Mar 17, 2016 · Terminated
  ADVIA CHEMISTRY ENZYMATIC CREATININE_2