ADVIA Centaur® AFP 10309980Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00630414177335), received between Jul 13, 2017 and Apr 12, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF A DISCORDANT ELEVATED ALPHA-FETOPROTEIN (AFP) RESULT FOR ONE PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR XP ANALYZER. THE INITIAL ELEVATED RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME ANALYZER AND PRODUCED A LOWER RESULT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S) BASED ON THE REPEAT TESTING. FOR TROUBLESHOOTING PURPOSES, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT, TESTED ON THE SAME ANALYZER AND ALSO PRODUCED A LOWER RESULT THAT THE INITIAL TEST. 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 19099962 ↗
• MalfunctionAug 5, 2021Off-Label Use; High Test Results; Off-Label Use; High Test Results

  A CUSTOMER OBSERVED DISCORDANT ELEVATED ADVIA CENTAUR XP AFP RESULTS FOR ONE SAMPLE FROM A (B)(6) MALE PATIENT. THE INITIAL RESULT WAS HIGHER THAN WAS EXPECTED (ACCORDING TO THE CUSTOMER, THE EXPECTED VALUE <8.1 NG/ML). THE CUSTOMER PERFORMED MANUAL DILUTION TESTING AT DILUTIONS OF 1:2, 1:4 AND 1:8 ON THE SAME DAY, ON THE SAME INSTRUMENT; THE RESULTS WERE ALSO HIGHER THAN EXPECTED. THE CUSTOMER RETESTED THE SAME SAMPLE ON A DIFFERENT ADVIA CENTAUR XP INSTRUMENT AND THE RESULT WAS ALSO HIGHER THAN EXPECTED. THE ADVIA CENTAUR XP RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE AFP METHOD AND THE RESULT WAS LOWER AND AGREES WITH THE CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER PROVIDED AN HISTORICAL ADVIA CENTAUR XP AFP RESULT FOR THIS PATIENT (TESTED (B)(6) 2021) THAT WAS ALSO ELEVATED. THIS RESULT WAS REPORTED TO THE PHYSICIAN, BUT IT IS UNKNOWN IF THE RESULT WAS QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284520 ↗
• MalfunctionAug 5, 2021Off-Label Use; High Test Results; Off-Label Use; High Test Results

  A CUSTOMER OBSERVED DISCORDANT ELEVATED ADVIA CENTAUR XP AFP RESULTS FOR ONE SAMPLE FROM A (B)(6)-YEAR-OLD MALE PATIENT. THE INITIAL RESULT WAS HIGHER THAN WAS EXPECTED (ACCORDING TO THE CUSTOMER, THE EXPECTED VALUE <8.1 NG/ML). THE CUSTOMER PERFORMED MANUAL DILUTION TESTING AT DILUTIONS OF 1:2, 1:4 AND 1:8 ON THE SAME DAY, ON THE SAME INSTRUMENT; THE RESULTS WERE ALSO HIGHER THAN EXPECTED. THE CUSTOMER RETESTED THE SAME SAMPLE ON A DIFFERENT ADVIA CENTAUR XP INSTRUMENT AND THE RESULT WAS ALSO HIGHER THAN EXPECTED. THE ADVIA CENTAUR XP RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE AFP METHOD AND THE RESULT WAS LOWER AND AGREES WITH THE CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER PROVIDED AN HISTORICAL ADVIA CENTAUR XP AFP RESULT FOR THIS PATIENT (TESTED 2021-06-08) THAT WAS ALSO ELEVATED. THIS RESULT WAS REPORTED TO THE PHYSICIAN, BUT IT IS UNKNOWN IF THE RESULT WAS QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284511 ↗
• MalfunctionAug 5, 2021Off-Label Use; High Test Results; Off-Label Use; High Test Results

  A CUSTOMER OBSERVED DISCORDANT ELEVATED ADVIA CENTAUR XP AFP RESULTS FOR ONE SAMPLE FROM A (B)(6) MALE PATIENT. THE INITIAL RESULT WAS HIGHER THAN WAS EXPECTED (ACCORDING TO THE CUSTOMER, THE EXPECTED VALUE <8.1 NG/ML). THE CUSTOMER PERFORMED MANUAL DILUTION TESTING AT DILUTIONS OF 1:2, 1:4 AND 1:8 ON THE SAME DAY, ON THE SAME INSTRUMENT; THE RESULTS WERE ALSO HIGHER THAN EXPECTED. THE CUSTOMER RETESTED THE SAME SAMPLE ON A DIFFERENT ADVIA CENTAUR XP INSTRUMENT AND THE RESULT WAS ALSO HIGHER THAN EXPECTED. THE ADVIA CENTAUR XP RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE AFP METHOD AND THE RESULT WAS LOWER AND AGREES WITH THE CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER PROVIDED AN HISTORICAL ADVIA CENTAUR XP AFP RESULT FOR THIS PATIENT (TESTED (B)(6) 2021) THAT WAS WAS ALSO ELEVATED. THIS RESULT WAS REPORTED TO THE PHYSICIAN, BUT IT IS UNKNOWN IF THE RESULT WAS QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284507 ↗
• MalfunctionApr 30, 2021False Positive Result; False Positive Result

  A CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP AFP RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING USING THE SAME METHOD. THE REPEAT-TESTING RESULTS WERE WITHIN THE ASSAY'S REFERENCE RANGE (<8.1 NG/ML). THE LOWER RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE, AND WERE REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR CHANGES IN TREATMENT RESULTING FROM THE DISCORDANT AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11754086 ↗
• MalfunctionAug 28, 2020High Test Results; High Test Results

  A CUSTOMER OBTAINED AN ELEVATED ADVIA CENTAUR XP AFP RESULT FOR ONE PATIENT, WHICH WAS NOT EXPECTED BASED ON THE CLINICAL PICTURE OF THE PATIENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED USING A DIFFERENT READYPACK. THE RETEST RESULTS WERE LOWER, AS EXPECTED. THE RETEST RESULTS WERE REPORTED TO THE PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE AND NO INSTRUMENT ERRORS WERE FOUND WITH THE SYSTEM DURING THE EVENT. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10468948 ↗
• MalfunctionDec 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT HAS A MEDICAL HISTORY OF THYROID CANCER. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9482585 ↗
• MalfunctionNov 14, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED AN INITIAL ELEVATED ALPHA-FETOPROTEIN (AFP) RESULT FOR A FEMALE PATIENT SAMPLE ON THE ADVIA CENTAUR XPT INSTRUMENT. THE PHYSICIAN QUESTIONED THE RESULT. THE SAME SAMPLE WAS RETESTED AND A LOWER RESULT WAS OBTAINED. A NEW SAMPLE DRAW FROM THE SAME PATIENT WAS TESTED ON THE ADVIA CENTAUR XPT AND ON AN ALTERNATE METHOD. THESE RESULTS WERE ALSO LOWER THAN THE INITIAL RESULT. ONLY THE INITIAL RESULT WAS ELEVATED. REPEAT TESTING WAS PERFORMED AND A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATE INITIAL AFP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9324255 ↗
• MalfunctionJun 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULTS COMPARED TO TWO ALTERNATE METHODS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666591 ↗
• MalfunctionJun 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULTS COMPARED TO TWO ALTERNATE METHODS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666590 ↗
• MalfunctionFeb 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XPT AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT WAS TESTED A MONTH LATER FOR AFP AND THE RESULT WAS LOW. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD FOR CONFIRMATION AND THE RESULT WAS LOW. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323770 ↗
• MalfunctionDec 27, 2018No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULTS WERE OBSERVED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A LIVER TRANSPLANTATION IN (B)(6) 2018, HOWEVER THE AFP MEASURED AT THIS HOSPITAL WAS NORMAL. THE PATIENT WAS DISCHARGED WITH NO ABNORMALITY DETECTED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULTS. MDR 1219913-2018-00308 WAS FILED FOR AN ELEVATED AFP RESULT ON THE SAME PATIENT FROM A DIFFERENT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199933 ↗
• MalfunctionDec 27, 2018No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULTS WERE OBSERVED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A LIVER TRANSPLANTATION IN (B)(6) 2018, HOWEVER THE AFP MEASURED AT THIS HOSPITAL WAS NORMAL. THE PATIENT WAS DISCHARGED WITH NO ABNORMALITY DETECTED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULTS. MDR 1219913-2018-00309 WAS FILED FOR AN ELEVATED AFP RESULT ON THE SAME PATIENT ON A DIFFERENT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199928 ↗
• MalfunctionDec 27, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT WAS OBSERVED ON A PATIENT SAMPLE. THE CUSTOMER PERFORMED REPEAT AFP TESTING ON THE SAME SAMPLE, AND INSTRUMENT WITHOUT ADDITIONAL SAMPLE CENTRIFUGATION, AND THE RESULTS WERE LOWER. THE ELEVATED AFP RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199490 ↗
• MalfunctionJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LOW ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE CUSTOMER REPEATS ANY SAMPLE WITH A RESULT LESS THAN THREE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS HIGHER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568996 ↗
• MalfunctionMay 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ELEVATED ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP AT ANOTHER CUSTOMER'S SITE AFTER OBTAINING ELEVATED RESULTS ON THE ADVIA CENTAUR CP. . THE ELEVATED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE NEGATIVE VALUE WAS ACCEPTED BY THE PHYSICIAN AS THIS WAS IN AGREEMENT WITH THE CLINICAL PICTURE OF THIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7530507 ↗
• MalfunctionMay 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ELEVATED ADVIA CENTAUR CP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE DURING PHYSICAL EXAMINATION. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP AT ANOTHER CUSTOMER'S SITE AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE NEGATIVE VALUE WAS ACCEPTED BY THE PHYSICIAN AS THIS WAS IN AGREEMENT WITH THE CLINICAL PICTURE OF THIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7530503 ↗
• MalfunctionJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT COMPARED TO AN ALTERNATE METHOD AND THE CLINICAL PICTURE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP AFP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6734490 ↗
• MalfunctionJul 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE DURING PHYSICAL EXAMINATION. THE PATIENT SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE HIGH. THE HIGH RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE PHYSICIAN ACCEPTED THE NEGATIVE RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6712077 ↗