ADVIA Centaur® ThCG 10308985Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00630414505176), received between Dec 7, 2017 and Dec 15, 2025 — classified as 9 injuries, 34 malfunctions.

The most frequently reported specific device problem is “High Test Results” (20 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, 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 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 ↗
• MalfunctionNov 17, 2023High 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. THCG REAGENT LOT 349 WAS IN USE AT THE TIME. AN INITIAL ELEVATED THCG RESULT WAS OBTAINED, AND IDENTIFIED AS DISCORDANT RELATIVE TO OTHER CLINICAL INDICATIONS. THE TEST WAS REPEATED TWICE USING THE SAME SAMPLE AND INSTRUMENT, AND LOWER RESULTS WERE PRODUCED. THE LOWER RESULTS WERE ACCEPTED AS CORRECT, AND THE PATIENT¿S RESULT REPORT WAS CORRECTED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161321 ↗
• MalfunctionMar 15, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ADVIA CENTAUR CP - TOTAL HCG (THCG) RESULT FOR ONE FEMALE PATIENT SAMPLE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR SYSTEM, AND THE RESULT WAS LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543951 ↗
• MalfunctionMar 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ADVIA CENTAUR XPT - TOTAL HCG (THCG) RESULT FOR A PREGNANT FEMALE PATIENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE SAMPLE WAS REMEASURED TWICE ON SAME ADVIA CENTAUR XPT, AND THE RESULTS WERE LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486178 ↗
• MalfunctionOct 21, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ADVIA CENTAUR XPT TOTAL HCG (THCG) SERUM SAMPLE RESULT THAT WAS REPORTED TO THE PHYSICIAN. THE FEMALE PATIENT WAS UNDERGOING IN VITRO FERTILIZATION (IVF) TREATMENT AND HAD RECEIVED AN EMBRYO TRANSPLANT TWO WEEKS BEFORE AND THE PHYSICIAN TOLD THE FEMALE PATIENT THAT SHE IS PREGNANT. THE PATIENT HAD PERFORMED SEVERAL COMMERCIALLY AVAILABLE URINE PREGNANCY TESTS AT HOME WITH NEGATIVE RESULTS, THEREFORE THE SAME SERUM SAMPLE WAS RETESTED BY THE CUSTOMER ON THE NEXT DAY USING THE SAME INSTRUMENT, SAME REAGENT LOT AND SAME CALIBRATOR LOT AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655928 ↗
• MalfunctionApr 7, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR XP TOTAL HCG (THCG) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT-TESTING RESULTS. FOLLOWING OBSERVATION OF AN ELEVATED INITIAL ADVIA CENTAUR XP THCG RESULT, THE PATIENT WAS RE-TESTED AT ANOTHER LABORATORY AND PRODUCED A NEGATIVE RESULT. THE CUSTOMER THEN PERFORMED REPEAT THCG TESTING ON THE ORIGINAL SAMPLE IN DUPLICATE, USING THE SAME ADVIA CENTAUR XP INSTRUMENT AS USED INITIALLY, AND A RESULT OF <2.0 MIU/ML WAS OBTAINED. THE LOWER RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047389 ↗
• MalfunctionMar 31, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED ADVIA CENTAUR XPT TOTAL HCG (THCG) ELEVATED RESULTS FROM FOUR SAMPLES THAT WERE CONSIDERED DISCORDANT COMPARED TO RESULTS GENERATED ON THE SAME SAMPLES WITH AN ALTERNATIVE ADVIA CENTAUR XPT. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED ADVIA CENTAUR XPT TOTAL HCG (THCG) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971703 ↗
• MalfunctionFeb 23, 2022High Test Results; High Test Results

  THE CUSTOMER HAS OBSERVED A DISCORDANT, ELEVATED ADVIA CENTAUR XPT TOTAL (B)(6) RESULT FOR ONE PATIENT. AN ELEVATED RESULT WAS OBTAINED AND QUESTIONED BY THE PHYSICIAN. TESTING WAS REPEATED ON THE SAME SAMPLE, PRODUCING A LOWER RESULT WHICH WAS ACCEPTED AS CORRECT. THERE ARE NO REPORTS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588059 ↗
• MalfunctionDec 2, 2021High Test Results; High Test Results

  A FALSELY ELEVATED ADVIA CENTAUR XP TOTAL HCG ASSAY RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE ELEVATED RESULT BASED ON CLINICAL EXPECTATION. THE SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XP, RESULTING LOWER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920670 ↗
• MalfunctionApr 14, 2021False Positive Result; False Positive Result

  A FALSELY ELEVATED (POSITIVE) ADVIA CENTAUR XP TOTAL HCG ASSAY RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULT, HOWEVER THE PATIENT CLAIMED NOT TO BE PREGNANT. THE SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XP, RESULTING LOWER (NEGATIVE). THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED (POSITIVE) ADVIA CENTAUR XP TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668400 ↗
• MalfunctionMar 10, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED RESULT FOR ONE PATIENT WHEN USING THE ADVIA CENTAUR CP TOTAL HCG (THCG) ASSAY WHICH WAS DISCORDANT RELATIVE TO PATIENT HISTORY AND REPEAT-TESTING BY AN ALTERNATE METHOD. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR CHANGE IN TREATMENT AS A RESULT OF THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452321 ↗
• MalfunctionFeb 18, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED ADVIA CENTAUR XPT TOTAL HCG (THCG) RESULTS FOR 3 PATIENTS WHICH WERE IDENTIFIED AS FALSELY-DEPRESSED RELATIVE TO REPEAT TESTING USING THE SAME METHOD AND AN ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343901 ↗
• MalfunctionJul 9, 2020High Test Results; High Test Results

  CUSTOMER OBTAINED AN ELEVATED ADVIA CENTAUR XP TOTAL HCG (THCG) RESULT THAT WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE ADVIA CENTAUR XP THCG ASSAY AND RESULTED LOWER. 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 10252027 ↗
• MalfunctionFeb 13, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XPT TOTAL HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE UPON REPEAT ON ANOTHER ADVIA CENTAUR XPT. THE INITIAL RESULT FOR THE PATIENT WAS NEGATIVE. THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE RESULT WAS NEGATIVE. THE RESULT WAS REPORTED AS NEGATIVE. 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 9708574 ↗
• MalfunctionFeb 13, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XPT TOTAL HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XPT AND THE SAME INSTRUMENT. THE RESULTS WERE NEGATIVE. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER ROUTINELY REPEATS POSITIVE SAMPLES ON A DIFFERENT SYSTEM. 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 9708572 ↗
• MalfunctionDec 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED A PATIENT RESULT ON A DILUTED (1:200) SAMPLE USING THE ADVIA CENTAUR CP TOTAL HCG (THCG) ASSAY THAT WAS ELEVATED COMPARED TO THE NEAT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED ADVIA CENTAUR CP THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9494715 ↗