ADVIA Centaur® ThCG 10308984Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00630414505152), received between Jul 11, 2017 and Sep 17, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A LOW ADVIA CENTAUR CP TOTAL HCG (THCG), LOT 357 RESULT THAT WAS DISCORDANT RELATIVE TO RETEST RESULTS. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A CORRECTED REPORT WAS ISSUED. 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 20239504 ↗
• MalfunctionSep 17, 2024High Readings; High Readings

  THE CUSTOMER OBTAINED AN ELEVATED ADVIA CENTAUR CP TOTAL HCG (THCG), LOT 357 RESULT THAT WAS DISCORDANT RELATIVE TO RETEST RESULTS. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A CORRECTED REPORT WAS ISSUED. 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 20239470 ↗
• MalfunctionSep 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING THCG LOT 357. AN ELEVATED ADVIA CENTAUR CP THCG RESULT WAS OBTAINED FOR A 45-YEAR-OLD FEMALE PATIENT; THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE TEST WAS REPEATED TWICE, AND BOTH REPEAT TESTS PRODUCED CONSISTENT LOWER RESULTS, WHICH WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212374 ↗
• MalfunctionAug 20, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTS OBSERVATION OF DIVERGENT ADVIA CENTAUR TOTAL HCG (THCG) RESULTS FOR ONE PATIENT WHEN RUNNING THCG LOT 355. AN INITIAL THCG RESULT ABOVE REFERENCE RANGE FOR NON-PREGNANT FEMALES WAS OBTAINED FOR A 31-YEAR-OLD FEMALE PATIENT (NO DETAILS PROVIDED). THE TEST WAS REPEATED USING THE SAME SAMPLE ACCORDING TO LOCAL PROTOCOL, AND THE SECOND TEST PRODUCED A RESULT BELOW ASSAY MEASURING INTERVAL (<4.0 MIU/ML). DUE TO THE OBSERVED DIFFERENCE BETWEEN RESULTS, A THIRD TEST WAS RUN, AND ANOTHER RESULT BELOW MEASURING INTERVAL WAS OBTAINED. A ¿NEGATIVE¿ RESULT WAS REPORTED FOR THE PATIENT. A WEEK LATER, WHILE VALIDATING A NEW THCG KIT LOT, THE AFFECTED SAMPLE WAS RE-TESTED FOLLOWING REFRIGERATED STORAGE AS PART OF THE EVALUATION. THIS SAMPLE, WHEN TESTED WITH NEW THCG LOT 357, PRODUCED A MUCH HIGHER RESULT (ABOVE REFERENCE RANGE FOR NON-PREGNANT FEMALES). WHEN THE SAME SAMPLE WAS REPEAT-TESTED, THE HIGHER RESULT WAS REPRODUCED. THE CUSTOMER IS UNCERTAIN WHICH RESULT TO CONSIDER CORRECT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003614 ↗
• MalfunctionMay 15, 2024High Test Results; High Test Results

  THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT RESULTS WHEN TESTING A PATIENT SAMPLE WITH ADVIA CENTAUR CP TOTAL HCG (THCG) LOT 357. THE PATIENT SAMPLE WAS TESTED IN DUPLICATE. THE REPLICATES WERE DISCORDANT FROM EACH OTHER, AND THE LOWER (NEGATIVE) RESULT WAS BELIEVED TO BE ACCURATE BASED ON THE PATIENT'S CLINICAL HISTORY. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327727 ↗
• MalfunctionMay 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF A DISCORDANT ELEVATED ADVIA CENTAUR CP TOTAL HCG (THCG) RESULT ON A PATIENT SAMPLE VERSUS REPEAT TESTING. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ADVIA CENTAUR CP INSTRUMENT FOUR TIMES AND LOWER RESULTS WERE OBTAINED. TWO REPEATS RESULTED AS ERRONEOUS AND THE LOWER RESULTS WITH VALUE <2.0 MIU/ML WERE REPORTED AS THE 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 19220832 ↗
• MalfunctionOct 24, 2023High Test Results; High Test Results

  A FALSELY ELEVATED TOTAL HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CENTAUR XPT SYSTEM. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS 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 ELEVATED TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998815 ↗
• MalfunctionApr 10, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT ON A FEMALE PATIENT, ON ADVIA CENTAUR XP (LOT 343). THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). AFTER RE-CENTRIFUGATION, THE SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XP WHICH ALSO GAVE A HIGH RESULT RELATIVELY. THE SAME SAMPLE WAS REPEATED ON TWO ALTERNATE METHODS AND THE RESULTS WERE SIMILAR TO THE ADVIA CENTAUR XP REPEAT RESULT. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS REPEATED ON THE ADVIA CENTAUR XP AND ALTERNATE METHOD 1, WHICH GAVE LOWER RESULTS WHEN COMPARED TO THE INITIAL RESULT. ON (B)(6) 2023, A NEW SAMPLE WAS COLLECTED FROM THE SAME PATIENT, WHICH WAS PROCESSED ONLY ON ALTERNATE METHOD 1, AS THE ADVIA CENTAUR XP REAGENT RAN OUT. THIS RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT ADVIA CENTAUR THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706453 ↗
• MalfunctionDec 27, 2022High Test Results; High Test Results

  THE CUSTOMER INFORMED SIEMENS THAT THEY HAVE OBSERVED DISCORDANT ADVIA CENTAUR XPT TOTAL HCG (THCG) RESULTS, WHERE THE INITIAL SAMPLE RESULT IS HIGH AND RETEST RESULT IS LOW (< 2). THE COMPLAINT INFORMATION INDICATES THAT THE INITIAL RESULTS ARE REPORTED TO PHYSICIAN(S), WHO QUESTION THE RESULTS BASED ON PATIENT CLINICAL HISTORY, AND SAMPLES ARE RETESTED. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052348 ↗
• MalfunctionNov 4, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED ADVIA CENTAUR CP TOTAL HCG RESULT FOR ONE PATIENT. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS HIGHER. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED TOTAL HCG PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731330 ↗
• MalfunctionDec 21, 2020High Test Results; High Test Results

  A DISCORDANT, INITIALLY HIGH TOTAL HCG (THCG) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ADVIA CENTAUR XPT INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAMPLE WAS REPEATED ON THE ORIGINAL ADVIA CENTAUR XPT AND A 2ND ADVIA CENTAUR XPT ON SITE. THE REPEAT RESULTS WERE LOWER THAN THE DISCORDANT RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECTED RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11051719 ↗
• MalfunctionDec 2, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (TOTAL HCG) RESULTS ON THE ADVIA CENTAUR XP INSTRUMENT. THE RESULTS WERE FROM FIVE PATIENTS' SAMPLES AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED ALTERNATE PATIENT SAMPLES AND AN ALTERNATE ADVIA CENTAUR XPT INSTRUMENT TO PERFORM REPEAT TESTING. THE CUSTOMER INFORMED SIEMENS THAT REPEAT RESULTS WERE LOWER (0.0 MIU/ML) AND MATCHED THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER STATED THAT CORRECTED REPORTS WERE ISSUED, AND THE RESULT OF 2.0 MIU/ML WAS REPORTED FOR THE FIVE PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TOTAL HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10932916 ↗
• MalfunctionMar 12, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR CP TOTAL HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT COMPARED TO A NEGATIVE HCG RESULT RUN AT ANOTHER HOSPITAL. THE NEGATIVE ALTERNATE HOSPITAL HCG RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP TOTAL HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9824956 ↗
• MalfunctionJul 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) RESULT WAS OBTAINED USING THE ADVIA CENTAUR XP TOTAL HCG ASSAY, WHICH WAS REPORTED TO THE PHYSICIAN AS (B)(6). THE PHYSICIAN REQUESTED QUANTITATIVE RESULTS FOR THE PATIENT AND THE SAMPLE WAS RUN IN TRIPLICATE. RESULTS OBTAINED WERE (B)(6), BUT A HIGHER CONCENTRATION WAS OBTAINED THAT THE INITIAL RESULT, THEREFORE THE SAMPLE WAS FLAGGED WITH A DELTA ERROR. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750743 ↗
• MalfunctionJun 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XP TOTAL HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. ANOTHER SAMPLE WAS TESTED AT A LATER DATE AND THE RESULT WAS HIGHER. THE HIGHER RESULT FIT THE CLINICAL PICTURE. THE INITIAL SAMPLE WAS REPEATED AND THE RESULT WAS HIGHER. THE LOW RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A CORRECTED REPORT WAS ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691677 ↗
• MalfunctionJun 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED ONE DISCORDANT HIGH RESULT USING ADVIA CENTAUR CP TOTAL HCG (THCG) LOT 029303. INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. QUALITY CONTROL WAS IN ACCEPTABLE RANGES. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND RESULT WAS IN LINE WITH THE CLINICAL HISTORY OF THE PATIENT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER ALSO TESTED THE SAME SAMPLE USING ADVIA CENTAUR XP THCG AND RESULTS WERE IN LINE WITH THE CLINICAL HISTORY OF THE PATIENT. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED AND NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8682889 ↗
• MalfunctionFeb 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED NON REPRODUCIBLE ADVIA CENTAUR CP TOTAL HCG (THCG) RESULTS ON ONE INSTRUMENT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON REPRODUCIBLE ADVIA CENTAUR CP THCG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8325269 ↗
• MalfunctionDec 18, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN INITIALLY ELEVATED ADVIA CENTAUR CP TOTAL HCG (THCG) RESULT THAT DID NOT REPEAT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED BY THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175093 ↗
• MalfunctionOct 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR CP TOTAL HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT OBTAINED ON A PATIENT SAMPLE, AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT HCG TESTING ON THE SAME SAMPLE, AND THE RESULT WAS LOWER. A NEW SAMPLE WAS TESTED AND THE HCG RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7948920 ↗
• MalfunctionJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR XP TOTAL HCG RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XP AND THE RESULT WAS HIGHER. THE PATIENT SAMPLE WAS TESTED ON THE OTHER ADVIA CENTAUR XP AND THE HIGH RESULT WAS CONFIRMED. THE HIGH RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7210173 ↗
• MalfunctionAug 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE POSITIVE ADVIA CENTAUR XPT TOTAL HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT OBTAINED BY THE CUSTOMER, AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. A NEW PATIENT SAMPLE WAS DRAWN, AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835629 ↗
• MalfunctionJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED A NON-REPRODUCIBLE, ELEVATED ADVIA CENTAUR XP TOTAL HCG (THCG) RESULT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6700820 ↗