Atellica CH CA_2 11097644Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00630414220697), received between Jun 14, 2021 and Oct 15, 2025 — classified as 28 malfunctions.

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

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. 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-0928-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. LOWER 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 ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304362 ↗
• MalfunctionSep 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THE INITIAL ELEVATED CALCIUM_2 (CA_2) RESULTS OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER WERE QUESTIONED BY THE PHYSICIAN(S) WHEN REPORTED. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. NO CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DID NOT PROVIDE THE PATIENT SAMPLE DATA. 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 23024669 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) RESULTS OBTAINED ON NINE (9) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON ALTERNATE ATELLICA CH 930 ANALYZERS. 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 CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287016 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) 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 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 CALCIUM_2 (CA_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286910 ↗
• MalfunctionJun 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. 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 CALCIUM_2 (CA_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286783 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) RESULTS OBTAINED ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED FOR ONE PATIENT ON THE SAME ATELLICA CH 930 ANALYZER AND FOR THE SECOND PATIENT 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 CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286686 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) 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 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 CALCIUM_2 (CA_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286581 ↗
• MalfunctionJun 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULTS OBTAINED ON THREE (3) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON ALTERNATE ATELLICA CH 930 ANALYZERS. HIGHER 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 DEPRESSED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286425 ↗
• MalfunctionJun 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUS CALCIUM_2 (CA_2) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER FOR TWO PATIENTS. AN ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) RESULT FOR ONE PATIENT SAMPLE WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULTS FOR THE OTHER PATIENT SAMPLE WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. HIGHER 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 DEPRESSED AND ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286328 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED CALCIUM_2 (CA_2) 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 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 CALCIUM_2 (CA_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286012 ↗
• MalfunctionJun 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULT OBTAINED ON ONE (1) PATIENT ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. 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 CALCIUM_2 (CA_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285972 ↗
• MalfunctionJun 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULTS OBTAINED ON TWO (2) PATIENTS ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON ALTERNATE ATELLICA CH 930 ANALYZERS. HIGHER 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 DEPRESSED CALCIUM_2 (CA_2) PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285207 ↗
• MalfunctionJun 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. 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 CALCIUM_2 (CA_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284764 ↗
• MalfunctionJan 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAMPLES WERE NOT REPEATED, AND THE CORRECT RESULTS FOR THE PATIENTS ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089956 ↗
• MalfunctionJan 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAMPLES WERE NOT REPEATED, AND THE CORRECT RESULTS FOR THE PATIENTS ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089915 ↗
• MalfunctionJan 6, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAMPLES WERE NOT REPEATED, AND THE CORRECT RESULTS FOR THE PATIENTS ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078276 ↗
• MalfunctionJan 6, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAMPLES WERE NOT REPEATED, AND THE CORRECT RESULTS FOR THE PATIENTS ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078265 ↗
• MalfunctionJan 3, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY DEPRESSED CALCIUM_2 (CA_2) RESULT WAS 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 THE SAME ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN. 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 21065995 ↗
• MalfunctionDec 29, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAMPLES WERE NOT REPROCESSED. THE CUSTOMER DID NOT PROVIDE THE INFORMATION REGARDING THE SPECIFIC SAMPLE IDENTIFIERS QUESTIONED BY THE PHYSICIAN(S). NO TREATMENT WAS PROVIDED OR DELAYED BASED ON THE ELEVATED RESULTS. THERE WAS NO DELAY IN REPORTING RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032168 ↗
• MalfunctionNov 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL AND AN ALTERNATE ATELLICA CH 930 ANALYZER AND THE RESULTS OBTAINED WERE SIMILAR TO THE INITIAL RESULTS. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA. THE CORRECT RESULTS FOR THE PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650217 ↗
• MalfunctionSep 19, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCORDANT ELEVATED CALCIUM_2 (CA_2) THREE PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER WHEN COMPARED TO THE HISTORICAL RESULTS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER HAS NOT PROVIDED THE REPEAT RESULTS FOR THESE PATIENT SAMPLES. THE CORRECT RESULTS ARE UNKNOWN FOR THESE PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CALCIUM_2 (CA_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258602 ↗
• MalfunctionJan 17, 2024High Test Results; High Test Results

  EIGHT (8) DISCORDANT FALSELY ELEVATED CALCIUM_2 (CA_2) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER AND LOWER RESULTS WERE OBTAINED. THE LOWER RESULTS WERE REPORTED TO THE PHYSICIAN(S) ON CORRECTED REPORTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524812 ↗
• MalfunctionSep 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULT ON A FEMALE PATIENT SAMPLE ON ATELLICA CH ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH ANALYZER, AND THE RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED AS CORRECT, AND A CORRECTED REPORT WAS PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682549 ↗
• MalfunctionJun 9, 2023High Test Results; High Test Results

  FALSELY ELEVATED CALCIUM_2 (CA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. 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 DISCORDANT, FALSELY ELEVATED CA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17096959 ↗
• MalfunctionMay 30, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CALCIUM_2 (CA_2) RESULT WAS OBTAINED ON 2 DIFFERENT PATIENT SAMPLES ON THE SAME DAY ON THE SAME ATELLICA CH 930 ANALYZER, SERIAL NUMBER (S/N): (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED ON A DIFFERENT ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS WERE LOWER AND CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025969 ↗