ADVIA® Chemistry XPT System 10723034Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 00630414595467), received between Aug 2, 2017 and Jul 16, 2025 — classified as 174 malfunctions.

The most frequently reported specific device problem is “High Test Results” (48 reports).

1 FDA recall record name this device's identifier.

13 other recalls cover devices cleared under the same FDA submission (K990346); 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.

Recalls naming this device

1. May 18, 2021Class IITerminated

   ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result

   Z-2014-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT ONE FALSELY DEPRESSED SODIUM TEST RESULT WAS OBTAINED FROM AN ADVIA CHEMISTRY XPT. THE INITIAL TEST RESULT WAS NOT RELEASED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT AND A HIGHER TEST RESULT WAS OBTAINED. THE REPEAT TEST RESULT WAS RELEASED TO THE PHYSICIAN(S) AS THE CORRECT TEST RESULT. 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 22520792 ↗
• MalfunctionMar 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WITH MULTIPLE ASSAYS ON AN ADVIA CHEMISTRY XPT SYSTEM. AMONG ALL THE INITIAL RESULTS, FEW RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) AS THEY WERE NOT REALISTIC. THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT SYSTEM. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE THE PATIENT RESULTS DATA TO SIEMENS. 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 21640622 ↗
• MalfunctionMar 13, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED CONCENTRATED CALCIUM_2 (CA_2C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE CUSTOMER DID NOT SPECIFY WHICH INSTRUMENT WAS USED FOR THE REPEAT TESTING. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THE CUSTOMER DID NOT PROVIDE SAMPLE DATA TO SIEMENS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA_2C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592124 ↗
• MalfunctionFeb 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT ONE PATIENT SAMPLE GAVE A FALSELY ELEVATED CALCIUM (CA_2C) TEST RESULT FROM AN ADVIA CHEMISTRY XPT SYSTEM. THE FALSELY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT SYSTEMS. THE REPEAT RESULT WAS LOWER, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396887 ↗
• MalfunctionFeb 10, 2025Low Test Results; Low Test Results

  THE CUSTOMER PROVIDED CALCIUM-2 (CA-2) RESULTS GENERATED ON THE ADVIA CHEMISTRY XPT ANALYZER FOR THIS EVENT. THE CUSTOMER DID NOT SPECIFY THE DATE OF TESTING FOR EACH SAMPLE. THEREFORE, THESE RESULTS WERE ALSO INCLUDED IN THE SUPPLEMENTAL REPORTS FOR MDR 2432235-2025-00047 AND MDR 2432235-2025-00048. ADDITIONALLY, THE CUSTOMER PROVIDED TWO SAMPLE IDENTIFIERS WITHOUT ANY RESULTS AND DID NOT PROVIDE THE CORRECT RESULTS FOR MOST SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349736 ↗
• MalfunctionFeb 10, 2025Low Test Results; Low Test Results

  THE CUSTOMER PROVIDED CALCIUM_2 (CA_2) RESULTS GENERATED ON THE ADVIA CHEMISTRY XPT ANALYZER FOR THIS EVENT. THE CUSTOMER DID NOT SPECIFY THE DATE OF TESTING FOR EACH SAMPLE. THEREFORE, THESE RESULTS WERE ALSO INCLUDED IN THE SUPPLEMENTAL REPORTS FOR MDR 2432235-2025-00047 AND MDR 2432235-2025-00049. ADDITIONALLY, THE CUSTOMER PROVIDED TWO SAMPLE IDENTIFIERS WITHOUT ANY RESULTS AND DID NOT PROVIDE THE CORRECT RESULTS FOR MOST SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349612 ↗
• MalfunctionFeb 10, 2025Low Test Results; Low Test Results

  THE CUSTOMER PROVIDED CALCIUM_2 (CA_2) RESULTS GENERATED ON THE ADVIA CHEMISTRY XPT ANALYZER FOR THIS EVENT. THE CUSTOMER DID NOT SPECIFY THE DATE OF TESTING FOR EACH SAMPLE. THEREFORE, THESE RESULTS WERE ALSO INCLUDED IN THE SUPPLEMENTAL REPORTS FOR MDR 2432235-2025-00048 AND MDR 2432235-2025-00049. ADDITIONALLY, THE CUSTOMER PROVIDED TWO SAMPLE IDENTIFIERS WITHOUT ANY RESULTS AND DID NOT PROVIDE THE CORRECT RESULTS FOR MOST SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349573 ↗
• MalfunctionJan 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS FOR ONE PATIENT SAMPLE THAT WAS OBTAINED ON THE ADVIA CHEMISTRY XPT ANALYZER WITH SERIAL NUMBER (B)(6). THE FALSELY ELEVATED RESULT (>40.0 MMOL/L) WAS OBTAINED FOUR TIMES AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAME SAMPLE ON AN ALTERNATE ADVIA CHEMISTRY XPT ANALYZER, RECEIVED A LOWER RESULT THAT WAS CONSIDERED CORRECT, AND ISSUED AN AMENDED REPORT. 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 21199284 ↗
• MalfunctionJan 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ABOVE ASSAY RANGE FLAGGED, CONCENTRATED CALCIUM_2 (CA_2C) AND CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED ON AN ALTERNATE ADVIA CHEMISTRY XPT ANALYZER. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS 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 21190802 ↗
• MalfunctionJan 13, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON 2 PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT. 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 FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143965 ↗
• MalfunctionAug 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT OUT-OF-RANGE QUALITY CONTROLS AND FALSELY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE SYSTEM. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION RELATED TO THIS INCIDENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TBIL_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955863 ↗
• MalfunctionAug 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS THAT WERE OBTAINED ON 2 PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE IDENTIFIED AS (B)(6) WAS REPEATED ON THE SAME ADVIA CHEMISTRY XPT SYSTEM AND AN ALTERNATE ADVIA CHEMISTRY XPT SYSTEM. THE SAMPLE IDENTIFIED AS (B)(6) WAS REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT SYSTEM. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE LOWER REPEAT RESULTS FROM THE ALTERNATE ADVIA CHEMISTRY XPT SYSTEM 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 FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945118 ↗
• MalfunctionJul 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS OF >40 MMOL/L WERE OBTAINED ON ALL PATIENT SAMPLES PROCESSED ON THE ADVIA CHEMISTRY XPT INSTRUMENT ON (B)(6) 2024. THEN, THE CUSTOMER RAN QUALITY CONTROLS, AND ALL THE QUALITY CONTROLS RECOVERED ABOVE THE UPPER LIMIT OF THE ASSAY RANGE (40 MMOL/L). THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED BETWEEN THREE ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENTS. THE REPEAT RESULTS RECOVERED LOWER AND WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798693 ↗
• MalfunctionMay 14, 2024Low Test Results; Low Test Results

  THE DISTRIBUTOR INFORMED SIEMENS THAT A FALSELY DEPRESSED CREATINE KINASE (CK_L) RESULT WAS REPORTEDLY OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CHEMISTRY 1800 INSTRUMENT AND ON THE SAME INSTRUMENT. THE REPEAT RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULT, MATCHED PATIENT¿S CONDITION AND WERE CONSIDERED CORRECT. THE REPEAT RESULT FROM AN ALTERNATE ADVIA CHEMISTRY 1800 INSTRUMENT 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 FALSELY DEPRESSED CK_L RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311983 ↗
• MalfunctionApr 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS FOR THREE (3) PATIENT SAMPLES ON AN ADVIA® CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY ELEVATED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). TWO OF THE SAMPLES WERE REPROCESSED ON THE ORIGINAL ADVIA® CHEMISTRY XPT SYSTEM. SAMPLE (B)(6) WAS ONLY REPROCESSED ON AN ALTERNATE ADVIA® CHEMISTRY XPT SYSTEM. LOWER RESULTS WERE OBTAINED ON THE REPROCESSED SAMPLES. THE LOWER 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 ERRONEOUSLY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132407 ↗
• MalfunctionJan 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED THAT DISCORDANT RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT INSTRUMENT DUE TO A CONTAMINATION ISSUE AFTER MAINTENANCE. SPECIFIC PATIENT RESULTS AND SAMPLE IDENTIFICATION WAS NOT PROVIDED BY THE CUSTOMER AT THE TIME OF FILING THIS REPORT. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602769 ↗
• MalfunctionJan 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON 2 PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT INSTRUMENT. ADDITIONALLY, A FALSELY DEPRESSED ENZYMATIC CREATININE_2 (ECRE_2) RESULT WAS OBTAINED ON ANOTHER PATIENT SAMPLE ON THE SAME INSTRUMENT. THE CO2_C RESULT FOR THE SAMPLE IDENTIFIED AS (B)(4) WAS REPORTED TO THE MEDICAL STAFF, BUT THE RESULT WAS NOT SEEN BY PHYSICIAN(S). THE CO2_C RESULT FOR THE SAMPLE IDENTIFIED AS (B)(4) AND THE ECRE_2 RESULT FOR THE SAMPLE IDENTIFIED AS (B)(4) WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT. 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 ERRONEOUS CO2_C AND ECRE_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566757 ↗
• MalfunctionNov 21, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE_2 (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A ADVIA CHEMISTRY XPT INSTRUMENT. THE FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON TWO ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENTS. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. A REPEAT RESULTS WERE REPORTED, AS THE 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 18185723 ↗
• MalfunctionJul 10, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED LOWER THAN THE ERRONEOUS RESULT AND WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291055 ↗
• MalfunctionJun 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ERRONEOUS RESULTS FOR MULTIPLE ASSAYS WERE GENERATED FOR PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) THE SAMPLES WERE REPEATED ON ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENTS. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AS THE CORRECT RESULTS, AS THEY AGREED WITH THE PATIENTS¿ MEDICAL HISTORY. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION AS THE CUSTOMER DID NOT QUANTIFY THE NUMBER OF SAMPLES IMPACTED BY THIS EVENT AND DID NOT PROVIDE SUPPORTING PATIENT DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100642 ↗
• MalfunctionMay 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ERRONEOUS ENZYMATIC CREATININE_2 (ECRE_2), CONCENTRATED CALCIUM_2 (CA_2C), AND TOTAL BILIRUBIN_2 (TBIL_2) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT. THE REPEAT RESULTS CORRELATED WITH PREVIOUS RESULTS FOR THE PATIENT. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE THE AFFECTED PATIENT RESULTS TO SIEMENS. THE MDR IS BEING FILED IN ABUNDANCE OF CAUTION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019489 ↗
• MalfunctionApr 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ERRONEOUS CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) AS THE MIDDLEWARE, CENTRALINK DATA MANAGEMENT SYSTEM, IDENTIFIED THESE RESULTS THROUGH DELTA CHECKS. THE SAMPLES WERE REPEATED ON ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT(S) AND THE RESULTS RECOVERED AS EXPECTED. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER DID NOT QUANTIFY HOW MANY PATIENTS WERE IMPACTED AND PROVIDED TWO EXAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732329 ↗
• MalfunctionApr 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ERRONEOUS CONCENTRATED CALCIUM_2 (CA_2C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) AS THE MIDDLEWARE, CENTRALINK DATA MANAGEMENT SYSTEM, IDENTIFIED THESE RESULTS THROUGH DELTA CHECKS. THE SAMPLES WERE REPEATED ON ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT(S) AND THE RESULTS RECOVERED AS EXPECTED. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER DID NOT QUANTIFY HOW MANY PATIENTS WERE IMPACTED AND ONLY PROVIDED ONE EXAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CA_2C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732328 ↗
• MalfunctionMar 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ONE DISCORDANT CALCIUM_2 CONCENTRATED (CA_2C) TEST RESULT WAS OBTAINED ON EACH OF TWELVE SAMPLES FROM AN ADVIA CHEMISTRY XPT INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT AND 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 16648906 ↗
• MalfunctionMar 13, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR CO2_C ON THE SAME ANALYZER, RECOVERING LOWER. THE LOWER 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 THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531150 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990346. One submission often covers many models, so check the product and lot details in each record.

• Z-0755-2016 · Oct 7, 2015 · Terminated
  ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access an
• Z-0183-2016 · Aug 28, 2015 · Terminated
  ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral sp
• Z-1399-2015 · Feb 11, 2015 · Terminated
  ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clini
• Z-0800-2014 · Dec 17, 2013 · Terminated
  Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
• Z-0940-2014 · Nov 6, 2013 · Terminated
  Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Syst
• Z-0344-2014 · Sep 3, 2013 · Terminated
  ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therape
• Z-0343-2014 · Sep 3, 2013 · Terminated
  ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therape
• Z-0352-2007 · Sep 8, 2006 · Terminated
  ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of
• Z-0353-2007 · Sep 8, 2006 · Terminated
  ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of th
• Z-0351-2007 · Sep 8, 2006 · Terminated
  ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of th
• Z-1448-06 · Feb 17, 2006 · Terminated
  ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
• Z-1450-06 · Feb 17, 2006 · Terminated
  Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
• Z-1449-06 · Feb 17, 2006 · Terminated
  ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.