Atellica CH 930 Analyzer 11067000Recalls & reported problems

Summary

The FDA's MAUDE database contains 679 adverse event reports that list this exact device (DI 00630414002163), received between Jun 20, 2018 and Sep 9, 2026 — classified as 4 injuries, 675 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (257 reports).

5 FDA recall records name this device's identifier, 2 still open.

7 other recalls cover devices cleared under the same FDA submission (K151767); 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. Nov 18, 2021Open, Classified

   (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

   Z-0449-2022 · Root cause: Software design · FDA record ↗

2. May 13, 2021Open, Classified

   Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

   Z-2026-2021 · Root cause: Component design/selection · FDA record ↗

3. Feb 27, 2020Terminated

   Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

   Z-1797-2020 · Root cause: Under Investigation by firm · FDA record ↗

4. Oct 11, 2019Terminated

   On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.

   Z-0862-2020 · Root cause: Under Investigation by firm · FDA record ↗

5. Sep 23, 2019Terminated

   Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

   Z-0581-2020 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 679 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Smoking; Sparking

  The customer reported that burning smell, smoke & spark observed on an Atellica CH 930 Analyzer. The customer stated that instrument extension plug was burnt and was unable to power on due to power tripping. There was no injury to the user during this event. There are no known reports of patient intervention or adverse health consequences due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50686355 ↗
• MalfunctionSep 9, 2026Low Test Results

  The customer reported that falsely depressed Ammonia (Amm) results were obtained on two patient samples on the Atellica CH 930 Analyzer.The Initial results were not reported to the physician. The same samples were repeated on alternate Atellica CH 930 Analyzer. The repeat results obtained were higher than the initial results and considered correct. The repeat results were reported as correct results to the physician.There are no known reports of patient intervention or adverse health consequences due to the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50686109 ↗
• MalfunctionSep 3, 2026Low Test Results

  The customer reported that they obtained an erroneously depressed Calcium_2 (CA_2) result on a patient sample on an Atellica CH 930 Analyzer.The initial result was not reported to the physician(s). The sample was repeated on the same analyzer four times. The repeat results obtained were consistent with the patient¿s clinical picture and considered correct. A repeat result of 2.665 was reported to the physician(s) as correct result. There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed CA_2 result.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50584370 ↗
• MalfunctionJun 23, 2026Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED MICROALBUMIN_2 (ALB_2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULT MATCHED THE PATIENT¿S CLINICAL ASSESSMENT. THE REPEAT RESULT WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED ALB_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595543 ↗
• MalfunctionMay 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER QUESTIONED THE ACCURACY OF THE INITIAL N LATEX FLC KAPPA RESULTS FOR A PATIENT SAMPLE TESTED ON THE ATELLICA CH 930 ANALYZER WITH SERIAL NUMBER (B)(6). THE CUSTOMER STATED THAT THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIANS AND THAT THE SAME SAMPLE AND ANALYZER WERE USED TO PERFORM REPEAT TESTING WITH A ×10 AUTO-DILUTION FACTOR. THE CUSTOMER CONSIDERED THE REPEAT RESULT OF 40.50 MG/L TO BE CORRECT AND REPORTED THE RESULT TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217017 ↗
• MalfunctionMay 15, 2026Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CALCIUM (CA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULT CORRELATED WITH PATIENT HISTORY/CLINICAL STATUS AND WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S).THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180744 ↗
• MalfunctionMay 11, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THE ERRONEOUSLY DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C), ENZYMATIC CREATININE_3 (ECRE3) AND TOTAL BILIRUBIN_2 (TBIL_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. FOR THE CO2_C THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). FOR ECRE3 AND TBIL_2 THE CUSTOMER DIDN'T PROVIDE THE INITIAL RESULTS. THEREFORE, THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN IS UNKNOWN. THE SAME SAMPLES WERE REPEATED ON THE ALTERNATE ATELLICA CH 930 ANALYZER¿S. THE REPEAT RESULTS CORRELATED WITH THE PATIENT¿S CLINICAL STATUS AND WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 25133983 ↗
• MalfunctionApr 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED AN INACCURACY WITH TWO GENTAMICIN (GENT) RESULTS OBTAINED FOR ONE PATIENT ON THE ATELLICA CH 930 ANALYZER WITH SERIAL NUMBER (B)(6). THE INITIAL RESULT OF 0.64 MG/L WAS REPORTED TO THE PHYSICIANS. AFTER OBSERVING THAT QUALITY CONTROL (QC) WAS OUT OF RANGE AND REPLACING THE DILUTION PROBE, REPEAT TESTING WAS PERFORMED ON THE SAME ANALYZER, YIELDING A RESULT OF 1.85 MG/L. THE SAME PATIENT SAMPLE WAS THEN TESTED ON AN ALTERNATE ATELLICA CH 930 ANALYZER WITH ACCEPTABLE QUALITY CONTROL, AND THE RESULT OF 1.0 MG/L WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED AND COMMUNICATED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926755 ↗
• MalfunctionApr 17, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ENZYMATIC CREATININE_3 (ECRE3) AND TOTAL BILIRUBIN_2 (TBIL_2) PATIENT RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER (S/N: (B)(6) V1.30.1). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON ALTERNATE INSTRUMENTS. THE REPEAT 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910119 ↗
• MalfunctionApr 9, 2026Low Test Results

  ONE FALSELY DEPRESSED CALCIUM TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE FROM AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS RELEASED TO A PHYSICIAN. THE SAME SAMPLE WAS TESTED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE RESULT FROM THE ALTERNATE ANALYZER WAS HIGHER, CONSIDERED CORRECT AND RELEASED TO A PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834596 ↗
• MalfunctionApr 8, 2026High Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT THE ERRONEOUS CARBON DIOXIDE, CONCENTRATED (CO2_C) AND CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ALTERNATE ATELLICA CH 930 ANALYZER¿S. THE REPEAT RESULTS CORRELATED WITH THE PATIENT¿S CLINICAL STATUS AND 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 CO2_C AND CREA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816620 ↗
• MalfunctionApr 7, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORTED THAT A FALSELY HIGH TEST RESULT FOR TOTAL BILIRUBIN (TBIL_2) WAS PRODUCED ON AN ATELLICA CH 930 ANALYZER. THE INITIAL TEST RESULT WAS RELEASED TO A PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE TEST RESULT DATA FROM THE ALTERNATE ANALYZER WAS CONSIDERED CORRECT AND RELEASED TO A PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802397 ↗
• MalfunctionApr 5, 2026Imprecise or Erratic Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED CREATININE_2 (CREA_2) AND CREATINE KINASE (CK_L) RESULTS WERE OBTAINED ON A PATIENT SAMPLE, AND A FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT WAS OBTAINED ON ANOTHER PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS MATCHED THE PATIENT¿S CLINICAL PICTURE. THE REPEAT RESULTS WERE DETERMINED TO BE CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CREA_2, CK_L, AND CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786638 ↗
• MalfunctionMar 30, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY DEPRESSED MICROALBUMIN_2 (ALB_2) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED ALB_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711187 ↗
• MalfunctionMar 20, 2026High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED INORGANIC PHOSPHORUS (IP) RESULT FOR ONE PATIENT SAMPLE WAS OBTAINED ON THE ATELLICA CH 930 ANALYZER AND REPORTED TO PHYSICIANS. THE CUSTOMER USED THE SAME SAMPLE TO PERFORM REPEAT TESTING ON AN ALTERNATE ATELLICA CH 930 ANALYZER, WITH QUALITY CONTROL (QC) RESULTS THAT WERE ACCEPTABLE, AND NOTED THAT THE REPEAT RESULT WAS CORRECT. THE CUSTOMER ISSUED A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649048 ↗
• MalfunctionMar 17, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON THREE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL RESULT, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616831 ↗
• MalfunctionMar 12, 2026Sparking

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPORTED THAT WHILE REMOVING THE QUICK-CONNECT TUBING ATTACHED TO THE LAMP/LIGHT-EMITTING DIODE (LED) ASSEMBLY, LAMP COOLANT SPILLED INTO THE DRIP TRAY IN THE CENTER REAR CABINET, OVERFLOWED ONTO THE 48-VOLT POWER SUPPLY, AND CAUSED A BURNING SMELL, A SPARK FROM THE POWER SUPPLY, AND SHUTDOWN OF AN ATELLICA CH 930 ANALYZER AT THE CUSTOMER¿S SITE. THERE WAS NO EXPOSURE TO BIOHAZARDOUS MATERIAL. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. THERE WAS NO SMOKE, FIRE, OR VISIBLE FLAME DUE TO THIS EVENT. THERE WAS NO INJURY TO THE OPERATOR DUE TO THIS EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578420 ↗
• MalfunctionMar 11, 2026Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON THREE (3) PATIENT SAMPLES ON THE ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED 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 FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566851 ↗
• MalfunctionMar 10, 2026High Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS CARBON DIOXIDE (CO2) AND CREATININE (CREA_2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON DIFFERENT ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 24557780 ↗
• MalfunctionMar 6, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER AND WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY. THE CORRECTED REPORTS WERE ISSUED. 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 24527901 ↗
• MalfunctionMar 5, 2026High Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS CARBON DIOXIDE, CONCENTRATED (CO2_C) AND CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT NOT QUESTIONED. THE SAMPLES WERE REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. 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 CO2_C AND CREA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516761 ↗
• MalfunctionMar 2, 2026High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT. THE REPEAT RESULT WAS REPORTED AS A CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492624 ↗
• MalfunctionMar 2, 2026Low Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORTED A FALSELY LOW CREATININE (CREA_2) TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE FROM AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS RELEASED TO A PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS HIGHER AND RELEASED TO A PHYSICIAN AS THE CORRECT RESULT. THE ANALYZER POSTED A "PHOTOMETRIC LAMP INTENSITY OUT OF RANGE" ERROR WHILE THE TEST WAS PROCESSING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE PHOTOMETRIC LAMP INTENSITY OUT OF RANGE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489769 ↗
• MalfunctionMar 2, 2026High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480734 ↗
• MalfunctionFeb 18, 2026Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN INITIAL ANALYZER. THE REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CORRELATE WITH RESULT ON ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED NA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374849 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151767. One submission often covers many models, so check the product and lot details in each record.

• Z-2027-2025 · May 22, 2025 · Open, Classified
  Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
• Z-1003-2024 · Dec 15, 2023 · Open, Classified
  Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
• Z-1870-2021 · May 4, 2021 · Open, Classified
  Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
• Z-0861-2021 · Dec 2, 2020 · Terminated
  Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quan
• Z-0148-2020 · Jul 30, 2019 · Terminated
  Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical
• Z-0782-2019 · Sep 26, 2018 · Terminated
  Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component s
• Z-0194-2019 · Jun 29, 2018 · Terminated
  Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.