ADVIA Centaur ThCGRecalls & reported problems across all models

We found 2 models of ADVIA Centaur ThCG by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2017 and Dec 15, 2025 — classified as 9 injuries, 56 malfunctions.

The most frequently reported specific device problem is “High Test Results” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ADVIA Centaur ThCG problems

ADVIA Centaur ThCG models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA Centaur® ThCG 10308985

  Visual, pregnancy hCG, prescription use
  43 reports
• ADVIA Centaur® ThCG 10308984

  Visual, pregnancy hCG, prescription use
  22 reports

Recent ADVIA Centaur ThCG adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

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

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR TOTAL HCG (THCG) PATIENT RESULT (AUTO DILUTED) WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING (MANUALLY DILUTED) AND ALTERNATE METHOD TESTING WHEN USING LOT 363. AN INITIAL ABOVE ASSAY RANGE RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE SAMPLE WAS AUTO-DILUTED (1:200) AND RETESTED, YIELDING A SIGNIFICANTLY HIGHER RESULT. THIS RESULT WAS CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS SUBSEQUENTLY AUTO DILUTED (1:10), WHICH OBTAINED A LOWER RESULT. THE SAMPLE WAS THEN RETESTED USING MANUAL DILUTION (1:20), WHICH PRODUCED A SIMILAR LOWER RESULT. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). INSTEAD, THE SAMPLE WAS SENT TO AN ALTERNATE LABORATORY AND TESTED USING AN ALTERNATE METHOD (VIDAS), WHICH YIELDED A LOWER RESULT. THE LOWER RESULTS WERE CONSIDERED CORRECT AND THE LOWER RESULT OBTAINED ON THE ALTERNATE METHOD WAS REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801777 ↗
• MalfunctionNov 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED ADVIA CENTAUR TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) PATIENT RESULT VS REPEAT TESTING. AFTER A WEEK FROM THE DATE OF EVENT THE PATIENT WAS REDRAWN AND PROCESSED ON THE ORIGINAL ANALYZER, AND THE RESULT WAS LOWER AND CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. THE NEW SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND PHYSICIAN(S) QUESTIONED THE INITIAL ELEVATED RESULT. THE ORIGINAL SAMPLE WAS REPEATED AGAIN ON THE ORIGINAL ANALYZER AND THE RESULT OBTAINED WAS LOWER AND CONSISTENT WITH THE NEW SAMPLE 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 23529784 ↗
• MalfunctionSep 15, 2025High 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 LOT 363. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. SUBSEQUENTLY, TWO NEW SAMPLES WERE DRAWN FROM THE AFFECTED PATIENT AND TESTED ON THE ORIGINAL ANALYZER, BOTH OF WHICH YIELDED LOWER RESULTS. THE INITIAL SAMPLE WAS ALSO RETESTED ON THE ORIGINAL ANALYZER WHICH OBTAINED A LOWER RESULT. THE LOWER RESULTS WERE CONSIDERED CORRECT AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049146 ↗
• MalfunctionJun 27, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ADVIA CENTAUR XP TOTAL HCG (THCG) RESULTS WERE OBTAINED ON A PATIENT SAMPLE WHEN USING REAGENT LOT# 285, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WITH AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER, AND OBTAINED A SIMILAR ELEVATED RESULT. THE SAMPLE WAS TESTED ON AN ALTERNATE TEST METHOD AND A LOWER (NEGATIVE) RESULT OBTAINED WHICH WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS RECENTRIFUGED AND TESTED ON THE ORIGINAL ANALYZER AND AGAIN OBTAINED AN ELEVATED RESULT. THE SAMPLE WAS THEN TREATED IN THE HBT TUBE AND OBTAINED A LOWER (NEGATIVE) RESULT. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344211 ↗
• MalfunctionMar 25, 2025High 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 362. AN INITIAL RESULT ABOVE REFERENCE RANGE (FOR NON-PREGNANT FEMALES) WAS OBTAINED FOR A 37-YEAR-OLD WOMAN IN FERTILITY TREATMENT. WHILE THE RESULT WAS ABOVE CUTOFF, IT WAS CONSIDERED VERY LOW FOR A POSITIVE THCG INDICATION. THIS RESULT WAS NOT RELEASED, AND THE TEST WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT TEST PRODUCED A MUCH LOWER RESULT, WHICH WAS CONSIDERED CONSISTENT WITH PATIENT CLINICAL CONDITION AND ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT EFFECTS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686582 ↗
• MalfunctionMar 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ADVIA CENTAUR XPT SYSTEM. THE REPROCESSED RESULT WAS LOWER AND MATCHED THE PATIENT¿S CLINICAL PICTURE. THE LOWER RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661672 ↗
• MalfunctionJan 15, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ADVIA CENTAUR XP TOTAL HCG (THCG), LOT 361, RESULTS ON 2 SAMPLES FROM THE SAME PATIENT THAT WERE DISCORDANT RELATIVE TO RETEST RESULTS. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAMPLES WERE RETESTED IN DUPLICATE ON THE SAME INSTRUMENT/DAY AND RESULTS WERE LOWER AS EXPECTED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158678 ↗
• MalfunctionDec 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN ELEVATED ADVIA CENTAUR XPT TOTAL HCG (THCG) PATIENT RESULT THAT WAS DISCORDANT RELATIVE TO RETESTING. THE INITIAL ELEVATED RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED IN DUPLICATE AND THE RESULTS WERE LOWER. A CORRECTED REPORT WAS ISSUED WITH THE LOWER RESULTS. 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 20817330 ↗
• MalfunctionOct 24, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ADVIA CENTAUR ADVIA CENTAUR TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING THCG LOT 357. AN INITIAL ELEVATED THCG RESULT WAS OBTAINED FOR A FEMALE PATIENT WITH ABNORMAL UTERINE BLEEDING. TESTING FOLLOWING 100- AND 200-FOLD DILUTION PRODUCED ¿ERROR¿ RESULTS. WHEN THE PATIENT¿S SAMPLE WAS TESTED USING AN HCG TEST STRIP, A NEGATIVE RESULT WAS OBTAINED, AND CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT EFFECTS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522888 ↗
• 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 ↗
• MalfunctionSep 7, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED RESULT FOR A FEMALE PATIENT WITH THE ADVIA CENTAUR XPT THCG LOT 359. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE REDRAWN SAMPLE WAS REPEATED ON THE SAME ANALYZER; THE SAMPLE RECOVERED LESS THAN THE ANALYTICAL MEASUREMENT RANGE VS. THE INITIAL RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS A CORRECT RESULT. A CORRECTED REPORT WAS ISSUED BASED ON THE REPEAT TESTING. 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 20164935 ↗
• 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 ↗

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