Atellica CH A1c_E 11097536Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00630414220505), received between Nov 11, 2025 and Jun 12, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “High Test Results” (20 reports).

3 FDA recall records name this device's identifier, 3 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. Jun 8, 2026Class IIOpen, Classified

   The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

   Z-2703-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 23, 2026Class IIOpen, Classified

   A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

   Z-1657-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Feb 9, 2022Class IIOpen, Classified

   Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

   Z-0929-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS A DISCORDANT ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT PATIENT SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. CORRECT RESULTS WERE OBTAINED AND WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492010 ↗
• MalfunctionJun 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED DISCORDANT ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS ON SIX (6) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON EITHER AN ALTERNATE ATELLICA CH 930 ANALYZER OR ON THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED (FOR TWO OF THE SAMPLES) TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459368 ↗
• MalfunctionJun 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS DISCORDANT ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS OBTAINED ON SIX (6) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE OR THE SAME ATELLICA CH 930 ANALYZER. CORRECT RESULTS WERE OBTAINED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458741 ↗
• MalfunctionJun 10, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS OBTAINED ON TEN (10) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457763 ↗
• MalfunctionMar 12, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 150283. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN BUT IT IS UNKNOWN IF IT WAS QUESTIONED. THE SAME SAMPLE WAS THEN RETESTED ON THE ORIGINAL ANALYZER, WHICH YIELDED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582543 ↗
• MalfunctionFeb 19, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT TWO PATIENT SAMPLES TESTED FOR ENZYMATIC HEMOGLOBIN A1C (A1C_E) ON AN ATELLICA CH 930 ANALYZER GENERATED ERROR MESSAGES INDICATING THE RESULTS WERE LESS THAN THE MEASURING INTERVAL. HOWEVER, RESULTS OF >14.0% WERE TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS) AND SUBSEQUENTLY REPORTED TO THE PHYSICIANS, WHO QUESTIONED THE RESULTS. BOTH SAMPLES WERE REPROCESSED MULTIPLE TIMES ON THE ORIGINAL ANALYZER FOR TROUBLESHOOTING PURPOSES. ALL REPEAT RESULTS RECOVERED LESS THAN MEASURING INTERVAL, YET THE LIS CONTINUED TO DISPLAY >14.0%. THE EXPECTED RESULTS FOR THESE TWO SAMPLES WERE <3.8%. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386398 ↗
• MalfunctionFeb 18, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A NEW SAMPLE WAS DRAWN AND PROCESSED TWICE ON AN ALTERNATE ATELLICA CH 930 ANALYZER. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND ONE RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380926 ↗
• MalfunctionFeb 10, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS ON TWO (2) PATIENT SAMPLES WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305096 ↗
• MalfunctionFeb 6, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279555 ↗
• MalfunctionFeb 6, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS WERE OBTAINED ON THREE (3) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLES WERE REPROCESSED ON EITHER THE SAME OR AN ALTERNATE ATELLICA CH 930 ANALYZER. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279378 ↗
• MalfunctionFeb 6, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND ONE RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279215 ↗
• MalfunctionFeb 4, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259929 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246573 ↗
• MalfunctionJan 29, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214778 ↗
• MalfunctionJan 29, 2026High Test Results

  THE CUSTOMER REPORTED A HISTORICAL ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209923 ↗
• MalfunctionJan 28, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. A SECOND DRAW SAMPLE FROM THE SAME PATIENT WAS PROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE LOWER RESULT WAS SIMILAR TO THE HISTORICAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203315 ↗
• MalfunctionJan 28, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. A SECOND DRAW FROM THE SAME PATIENT WAS PROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE ELEVATED RESULT WAS CONSIDERED ERRONEOUS BY THE CUSTOMER. A THIRD SAMPLE WAS COLLECTED AND PROCESSED OBTAINING A LOWER RESULT SIMILAR TO THE SECOND DRAW SAMPLE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203194 ↗
• MalfunctionJan 26, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A SECOND SAMPLE FROM THE SAME PATIENT WAS PROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184269 ↗
• MalfunctionJan 22, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAME PATIENT SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147145 ↗
• MalfunctionJan 5, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND IT IS UNKNOWN IF THE RESULT WAS QUESTIONED. THE SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956088 ↗
• MalfunctionJan 5, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED HEMOGLOBIN A1C (A1C_E) RESULTS OBTAINED ON SIXTY-THREE (63) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS A1C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956024 ↗
• MalfunctionDec 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED HEMOGLOBIN A1C (A1C_E) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE, ALONG WITH A REDRAW WAS REPROCESSED ON THE NEXT DAY ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE SAME LOWER RESULT WAS OBTAINED FOR BOTH REPEATS, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831855 ↗
• MalfunctionDec 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPROCESSED RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS AND MATCHED THE PATIENT¿S CLINICAL PICTURE. FOR SAMPLE IDENTIFIER (B)(6), THE SAMPLE WAS SENT OUT FOR ALTERNATE METHODOLOGY TESTING. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION, AND IT IS UNKNOWN WHETHER THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). FOR THE OTHER SAMPLE IDENTIFIERS, THE REPROCESSED RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776227 ↗
• MalfunctionDec 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER. THE REPROCESSED RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT¿S CLINICAL PICTURE. THE REPROCESSED RESULT 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 ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776225 ↗
• MalfunctionNov 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN ERRONEOUSLY DEPRESSED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS NOT QUESTIONED. THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER. ADDITIONALLY, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL ANALYZER. BOTH THE REPROCESSED AND REDRAWN SAMPLE RESULTS WERE HIGHER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT¿S CLINICAL HISTORY. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520184 ↗