ADVIA® 1800 Analyzer 10315183Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00630414534794), received between Jun 30, 2017 and Jan 9, 2025 — classified as 1 injury, 149 malfunctions.

The most frequently reported specific device problem is “High Test Results” (54 reports).

14 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT A 4274 ISE CALIBRATION SLOPE ERROR WAS GENERATED FROM THE ION SELECTIVE ELECTRODE (ISE) MODULE ON AN ADVIA 1800 CHEMISTRY SYSTEM. THE ERROR IS POSTED IN THE ALARM LOG AND THE ERROR INFORMS THE OPERATOR TO REPEAT THE ISE CALIBRATION. SODIUM, POTASSIUM AND CHLORIDE PATIENT SAMPLE TEST RESULTS WERE FLAGGED WITH AN ASTERISK (*) INDICATING A CALIBRATION ERROR. THE INITIAL TEST RESULTS WERE NOT RELEASED TO A PHYSICIAN. THERE ARE NO REPORTS OF INJURY OR A DELAY IN REPORTING TEST RESULTS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118491 ↗
• MalfunctionNov 28, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL AND ALTERNATE ADVIA 1800 ANALYZERS. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS AND WERE IN LINE WITH LAB EXPECTATIONS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND THE REPEAT RESULTS FROM THE ALTERNATE ANALYZER WERE REPORTED 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 20804235 ↗
• MalfunctionNov 28, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE IDENTIFIED AS (B)(6) WAS REPROCESSED ON THE ORIGINAL ANALYZER, HOWEVER, THE SAMPLES IDENTIFIED AS (B)(6) WERE REPROCESSED ON AN ALTERNATE ADVIA 1800 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS AND WERE IN LINE WITH LAB EXPECTATIONS. THE REPEAT RESULTS WERE CONSIDERED CORRECT, AND THE REPEAT RESULTS WERE REPORTED 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 20804234 ↗
• MalfunctionNov 7, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT. 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 A FALSELY DEPRESSED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630064 ↗
• MalfunctionNov 7, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL RESULTS. 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 FALSELY DEPRESSED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630034 ↗
• MalfunctionSep 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE ADVIA 1800 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULTS AND WERE CONSISTENT WITH THE PATIENTS¿ CLINICAL HISTORIES. 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 ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207212 ↗
• MalfunctionSep 10, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE ADVIA 1800 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULTS AND WERE CONSISTENT WITH THE PATIENTS¿ CLINICAL HISTORIES. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER ONLY PROVIDED A SUBSET OF FALSELY ELEVATED CO2_C RESULTS OBTAINED ON PATIENT SAMPLES AND INDICATED THAT ERRONEOUS CALCIUM_2 (CA_2) RESULTS WERE ALSO OBTAINED ON PATIENT SAMPLES. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSELY ELEVATED CO2_C AND CA_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183559 ↗
• MalfunctionSep 6, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES ON THE ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE AUTO REPEATED ON THE ORIGINAL INSTRUMENT. THE AUTO-REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS. THE AUTO-REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE IS 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 20157617 ↗
• MalfunctionSep 5, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS ON THREE (3) PATIENT SAMPLES ON AN ADVIA® 1800 CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE AUTO REPROCESSED ON THE SAME ADVIA® 1800 CLINICAL CHEMISTRY SYSTEM AND THE RESULTS RECOVERED WITHIN THE NORMAL RANGE. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ADVIA® 1800 CLINICAL CHEMISTRY SYSTEM AND THE RESULTS RECOVERED WITHIN THE NORMAL RANGE. THE REPROCESSED RESULTS WERE REPORTED TO THE PHYSICIAN AS THE CORRECT RESULTS. THE CUSTOMER DECLINED TO PROVIDE THE INFORMATION ABOUT CORRECT REPORTED RESULTS. THERE IS 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 20144978 ↗
• MalfunctionAug 21, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON EIGHTEEN PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES IDENTIFIED AS (B)(6) WERE REPEATED ON AN ALTERNATE ADVIA 1800 ANALYZER, AND THE OTHER SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH (B)(6) ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULTS AND FIT THE PATIENTS' CLINICAL HISTORIES. 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 ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013099 ↗
• MalfunctionAug 20, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE IDENTIFIED AS (B)(6) WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER, AND THE SAMPLE IDENTIFIED AS (B)(6) WAS REPEATED ON AN ALTERNATE ADVIA 1800 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULTS AND FIT THE PATIENTS' CLINICAL HISTORIES. 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 ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008308 ↗
• MalfunctionJun 10, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY 1800 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND WAS CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. 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 ELEVATED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505587 ↗
• MalfunctionNov 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THREE FALSELY DEPRESSED CREATININE RESULTS AND ONE FALSELY DEPRESSED CARBON DIOXIDE RESULT WERE OBTAINED ON FOUR PATIENT SAMPLE USING AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES FOR SAMPLE IDS (B)(6), (B)(6), AND (B)(6), WERE REPEATED ON AN ALTERNATE ADVIA 1800. THE SAME SAMPLE FOR SAMPLE ID (B)(6) WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). 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 18188338 ↗
• MalfunctionNov 8, 2023High Test Results; High Test Results

  THREE (3) DISCORDANT FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA® 1800 CLINICAL CHEMISTRY SYSTEM. THE FALSELY ELEVATED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ADVIA® 1800 CLINICAL CHEMISTRY SYSTEM. THE LOWER REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091116 ↗
• MalfunctionDec 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MULTIPLE FALSELY DEPRESSED PATIENT RESULTS WERE OBTAINED ON MULTIPLE COMPLETE METABOLIC PANEL ASSAYS ON AN ADVIA 1800 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA 1800 INSTRUMENT. THE REPEATED RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE SPECIFIC ASSAYS OR RESULTS. THE CUSTOMER ALSO INDICATED THAT THERE WAS A DELAY OF TWO HOURS IN PROCESSING URINE DRUG SCREEN TESTS DUE TO RUNNING MAINTENANCE AND QUALITY CONTROL ON THE ORIGINAL INSTRUMENT. 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 16067562 ↗
• MalfunctionNov 23, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA 1800 INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE DISCORDANT RESULT. THE REPEAT 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 FALSELY DEPRESSED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853884 ↗
• MalfunctionNov 2, 2022Low Test Results; Low Test Results

  ONE FALSELY DEPRESSED CREATININE (ENZYMATIC, ECRE_2) TEST RESULT WAS OBTAINED ON ONE PATIENT SAMPLE FROM AN ADVIA 1800 CHEMISTRY SYSTEM. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME ADVIA 1800 AND A HIGHER TEST RESULT WAS OBTAINED. THE REPEAT TEST 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 FALSELY DEPRESSED ECRE_2 TEST RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713845 ↗
• MalfunctionSep 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FALSELY ELEVATED CALCIUM_2 (CA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CHEMISTRY 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY 1800 INSTRUMENT. THE REPEAT RESULTS FROM AN ALTERNATE ADVIA CHEMISTRY 1800 INSTRUMENT 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 CA_2 RESULTS. THIS MDR IS BEING FILED IN AN ABUNDANCE OF CAUTION AS THE CUSTOMER DID NOT PROVIDE PATIENT DATA FOR ALL OF THE AFFECTED SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511183 ↗
• MalfunctionAug 9, 2022High Test Results; High Test Results

  FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON SEVEN PATIENT SAMPLES FROM AN ADVIA CHEMISTRY 1800 INSTRUMENT. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE EITHER REPEATED ON AN ALTERNATE INSTRUMENT OR BOTH INSTRUMENTS. THE LOWER REPEAT RESULTS FROM THE ALTERNATE INSTRUMENT WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO 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 15192545 ↗
• MalfunctionAug 9, 2022High Test Results; High Test Results

  FALSLEY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA CHEMSITRY 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED ON THE ORIGINAL INSTRUMENT AND ONE OF THESE SAMPLES WAS REPROCESSED ON AN ALTERNATE INSTRUMENT. THE LOWER REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190224 ↗
• MalfunctionJul 13, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED CONCENTRATED CALCIUM_2 (CA_2C) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, AND THE SAMPLE RECOVERED SIMILARLY. BASED ON THESE DEPRESSED RESULTS, THE PATIENT WAS SENT TO THE EMERGENCY ROOM, WHERE THE LAB PROCESSED THE SAME PATIENT SAMPLE AGAIN. THE SECOND REPEAT RESULT WAS HIGHER THAN THE DISCORDANT RESULTS. THE HIGHER REPEAT 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 FALSELY DEPRESSED CA_2C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008755 ↗
• MalfunctionJun 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER SPILLED LIQUID ON THE ADVIA 1800 CHEMISTRY SYSTEM AND ALLEGED THE FEELING OF CURRENT WITHIN THE BODY WHILE CLEANING THE SPILL. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC), AND SIEMENS INSTRUCTED THE CUSTOMER TO POWER OFF THE SYSTEM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LIQUID SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14700220 ↗
• MalfunctionJun 3, 2022Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW CREATININE (CREA) RESULT AND CARBON DIOXIDE (CO2) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 1800 CHEMISTRY SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED FOR CREA AND CO2 ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT 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 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595324 ↗
• MalfunctionMay 11, 2022High Test Results; High Test Results

  FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES ON AN ADVIA CHEMISTRY 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY 1800 INSTRUMENT. THE REPEAT RESULTS FROM AN ALTERNATE INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14362156 ↗
• MalfunctionApr 18, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON 6 PATIENT SAMPLES ON AN ADVIA CHEMISTRY 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT HISTORY. 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 CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135058 ↗

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-2014-2021 · May 18, 2021 · Terminated
  The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral
• 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-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-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-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-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.
• Z-1448-06 · Feb 17, 2006 · Terminated
  ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.