Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl- 11099315Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00630414596518), received between Apr 23, 2020 and May 7, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (18 reports).

12 other recalls cover devices cleared under the same FDA submission (K151767, K222438); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionMay 7, 2026Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER AND TWICE ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPROCESSED RESULTS MATCHED THE CLINICAL HISTORY AND WERE CONSIDERED CORRECT. THE REPROCESSED RESULT FROM AN ALTERNATE ANALYZER WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED K RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111289 ↗
• MalfunctionDec 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON TWO DIFFERENT ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS FROM THE ALTERNATE ATELLICA CH 930 ANALYZERS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 23786968 ↗
• MalfunctionSep 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) 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 SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER. THE REPROCESSED RESULT WAS HIGHER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT¿S HISTORY. 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 DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039875 ↗
• MalfunctionSep 8, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS OBTAINED ON TWO (2) PATIENT SAMPLES USING AN A-LYTE INTEGRATED MULTISENSOR (IMT) ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, 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 SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991789 ↗
• MalfunctionAug 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THEY OBTAINED AN ERRONEOUSLY DEPRESSED POTASSIUM (K) RESULT ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED POTASSIUM (K) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926800 ↗
• MalfunctionAug 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926509 ↗
• MalfunctionJul 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS OBTAINED ON TWO 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 ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. 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 22477859 ↗
• MalfunctionJul 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT 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. A NEW SAMPLE WAS REDRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REDRAWN RESULT OBTAINED WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. 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 22477673 ↗
• MalfunctionJul 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, 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 SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375838 ↗
• MalfunctionMay 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN INCREASE IN ELEVATED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES, INCLUDING AN ERRONEOUSLY ELEVATED NA 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 QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CI 1900 ANALYZER AND ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER NO LONGER RECALLED CERTAIN DETAILS, SUCH AS THE DATE OF TESTING AND THE REPROCESSED RESULT(S) FOR THE AFFECTED SAMPLE, AS THE EVENT OCCURRED SEVERAL MONTHS AGO. FOR THE OTHER ELEVATED SAMPLES, IT IS UNCLEAR WHETHER ANY ERRONEOUS RESULTS WERE OBTAINED, AS THE PATIENT RESULTS DATA WERE NOT PROVIDED TO SIEMENS AND THE CUSTOMER COULD NOT RECALL ANY DETAILS, INCLUDING SAMPLE IDENTIFIERS, DATE(S) OF TESTING, OR THE RESULTS OBTAINED. 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 22112775 ↗
• MalfunctionMay 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT TWO ERRONEOUSLY ELEVATED SODIUM (NA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER AND A HIGHER RESULT WAS OBTAINED WHICH WAS CONSIDERED ERRONEOUS AND NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM AND A LOWER RESULT WAS OBTAINED. THE LOWER REPROCESSED RESULT MATCHED THE PATIENT¿S CLINICAL HISTORY, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975141 ↗
• MalfunctionApr 30, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938450 ↗
• MalfunctionFeb 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED POTASSIUM (K) RESULT ON ONE (1) PATIENT SAMPLE USING AN A-LYTE INTEGRATED MULTISENSOR (IMT) OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED POTASSIUM (K) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368366 ↗
• MalfunctionFeb 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE USING AN A-LYTE INTEGRATED MULTISENSOR (IMT) OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368352 ↗
• MalfunctionJan 28, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A POSITIVE BIAS FOR CHLORIDE (CL) ON A-LYTE INTEGRATED MULTISENSOR (IMT) RESULTS SINCE (B)(6) 2021, ON AN ATELLICA CH 930 ANALYZER. THERE ARE NO ALLEGATIONS OF DISCORDANT PATIENT RESULTS, AND THE REPORTING OF PATIENT RESULTS WAS NOT DELAYED AT ANY POINT, NOR DID ANY RESULTS HAVE A POTENTIAL IMPACT ON THE DIAGNOSIS, MEDICATION, PROCEDURE, TREATMENT, PATIENT, AND/OR PUBLIC HEALTH INTERVENTIONS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ANY CHLORIDE (CL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257986 ↗
• MalfunctionJan 2, 2025High Test Results; High Test Results

  THROUGH THE REVIEW OF INSTRUMENT DATA, SIEMENS IDENTIFIED AN ERRONEOUSLY ELEVATED SODIUM (NA) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND 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 NA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053736 ↗
• MalfunctionDec 5, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED PATIENT SAMPLE RESULT WITH SODIUM (NA) WAS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ABL RADIOMETER (BLOOD GAS ANALYZER). A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. A SIMILAR ERRONEOUS PATIENT RESULT WAS OBTAINED AS ON THE ORIGINAL ATELLICA ® CH 930 ANALYZER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856198 ↗
• MalfunctionNov 7, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED SODIUM (NA) RESULTS ON NINE (9) PATIENTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE LOWER 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 THE ERRONEOUSLY ELEVATED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631337 ↗
• MalfunctionAug 5, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON A PATIENT SAMPLE USING AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER AND THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS RECOVERED HIGHER, MATCHING THE PATIENT¿S HISTORY AND WERE CONSIDERED CORRECT. THE RESULT FROM THE ALTERNATE ATELLICA CH 930 ANALYZER WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907505 ↗
• MalfunctionMay 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A HIGHER REPROCESSED RESULT WAS OBTAINED AND MATCHED THE PATIENT¿S PREVIOUS HISTORY. THE HIGHER 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 DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333259 ↗
• MalfunctionMay 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON TWO (2) ALTERNATE ATELLICA CH 930 ANALYZERS AND HIGHER RESULTS WERE OBTAINED. THE REPROCESSED RESULTS OBTAINED WERE CONSISTENT AND CONSIDERED CORRECT. NO CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280333 ↗
• MalfunctionJan 2, 2024High Test Results; High Test Results

  TWO (2) DISCORDANT FALSELY ELEVATED POTASSIUM (K) RESULTS ON A PATIENT SAMPLE WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. LATER, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON A NON-SIEMENS SYSTEM AT AN ALTERNATE FACILITY. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED TO THE PHYSICIAN(S). NO CORRECTED REPORT WAS ISSUED FOR THE FALSELY ELEVATED RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION AND ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED POTASSIUM (K) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424455 ↗
• MalfunctionSep 29, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED POTASSIUM (K) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE NON-SIEMENS INSTRUMENTS AND OBTAINED FALSELY ELEVATED RESULTS. THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) AND WAS REDRAWN. THE NEW SAMPLE WAS PROCESSED ON TWO ALTERNATE NON-SIEMENS INSTRUMENTS AND RECOVERED LOWER RESULTS. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED POTASSIUM (K) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842528 ↗
• MalfunctionJun 27, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED SODIUM (NA) RESULT ON ONE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL ATELLICA CH INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS CONSIDERED AS CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207374 ↗
• MalfunctionApr 23, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED POTASSIUM TEST RESULT WAS OBTAINED FROM AN ATELLICA CH 930 INSTRUMENT. THE INITIAL RESULT WAS FLAGGED WITH A DELTA CHECK ERROR AND NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED AND REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED POTASSIUM TEST RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993577 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151767, K222438. 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-0449-2022 · Nov 18, 2021 · Open, Classified
  Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. S
• Z-2026-2021 · May 13, 2021 · Open, Classified
  Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
• 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-1797-2020 · Feb 27, 2020 · Terminated
  Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
• Z-0862-2020 · Oct 11, 2019 · Terminated
  Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed
• Z-0581-2020 · Sep 23, 2019 · Terminated
  Atellica CH 930 Analyzer
• 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 clini
• 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.