ADVIA Centaur® AFP 10309979Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00630414177328), received between Sep 6, 2017 and Mar 20, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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.

• MalfunctionMar 20, 2024Low Test Results; Low Test Results

  A CUSTOMER OBTAINED A LOW INITIAL RESULT WITH THE ADVIA CENTAUR AFP ASSAY (LOT 280) ON AN ADVIA CENTAUR XPT INSTRUMENT. THE INITIAL RESULT WAS CONSIDERED DISCORDANT RELATIVE TO THE HIGHER RETEST RESULT OBTAINED WHEN THE SAME SAMPLE WAS RETESTED ON THE SAME INSTRUMENT ON A DIFFERENT DAY. THE INITIAL RESULT WAS REPORTED AND QUESTIONED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT LOW AFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943026 ↗
• MalfunctionMar 20, 2024Low Test Results; Low Test Results

  A CUSTOMER OBTAINED A LOW INITIAL RESULT WITH THE ADVIA CENTAUR AFP ASSAY (LOT 280) ON AN ADVIA CENTAUR XPT INSTRUMENT. THE INITIAL RESULT WAS CONSIDERED DISCORDANT RELATIVE TO THE HIGHER RETEST RESULT OBTAINED WHEN THE SAME SAMPLE WAS RETESTED ON THE SAME INSTRUMENT ON A DIFFERENT DAY. THE INITIAL RESULT WAS REPORTED AND QUESTIONED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT LOW AFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940920 ↗
• MalfunctionJan 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A DISCORDANT ELEVATED ALPHA-FETOPROTEIN (AFP, LOT 276) RESULT ON ONE PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR CP INSTRUMENT (S/N: (B)(6). THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS RETESTED AGAIN ON THE SAME INSTRUMENT AND OBTAINED A LOWER RESULT. A NEW SAMPLE WAS ALSO DRAWN FROM THE SAME PATIENT AND TESTED ON THE SAME INSTRUMENT, OBTAINED A LOWER RESULT THAT MATCHED THE PREVIOUSLY RETESTED RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED AFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552820 ↗
• MalfunctionMay 8, 2020Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  A CUSTOMER OBTAINED A DISCORDANT HIGH RESULT ON ONE PATIENT SAMPLE WITH ADVIA CENTAUR XP AFP. THE PHYSICIAN QUESTIONED THE RESULT. THE SAME SAMPLE WAS RETESTED ON THE SAME DAY AND A SIMILAR HIGH RESULT WAS OBTAINED. THE SAME SAMPLE WAS TESTED WITH 2 ALTERNATE METHODS. THE PHYSICIAN ACCEPTED THE ALTERNATE METHOD RESULT AS VALID BASED ON THE PATIENT'S CLINICAL PICTURE. 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 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10040507 ↗
• MalfunctionDec 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR CP ALPHA-FETOPROTEIN (AFP) RESULT COMPARED TO REPEAT TESTING OF THE SAMPLE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP AFP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9416042 ↗
• MalfunctionDec 17, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE LOWER. 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 8171216 ↗
• MalfunctionOct 22, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT WAS OBSERVED ON A PATIENT SAMPLE, AND THE RESULT DID NOT CORRESPOND TO A PREVIOUS LOWER RESULT. THE CUSTOMER PERFORMED REPEAT AFP TESTING ON THE SAME SAMPLE AND INSTRUMENT, 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 7993084 ↗
• MalfunctionSep 11, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN INITIAL ELEVATED ADVIA CENTAUR XP AFP RESULT COMPARED TO DUPLICATE, REPEAT TESTING OF THE SAMPLE. 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 7863683 ↗
• MalfunctionSep 5, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ELEVATED RESULT FOR ADVIA CENTAUR XP AFP THAT WAS LOWER UPON REPEAT TESTING. 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 7848012 ↗
• MalfunctionAug 31, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE UPON REPEAT. THE INITIAL RESULT WAS <2.5. THE CUSTOMER REPEATS ALL LESS THAN 2.5 RESULTS. THE PATIENT SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS NEGATIVE THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. A NEW PATIENT SAMPLE WAS RECCEIVED AND TESTED IN TRIPLICATE. THE RESULTS WERE NEGATIVE. 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 7837188 ↗
• MalfunctionJul 6, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XPT AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE WHEN REPEATED. THE INITIAL RESULT HAD A VALUE GREATER THAN 1000 NG/ML THE PATIENT SAMPLE WAS REPEATED ON THE SECOND ADVIA CENTAUR XPT AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED IN AN ALTERNATE METHOD AND THE RESULT WAS ALSO HIGH. 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 7665925 ↗
• MalfunctionJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT WAS OBSERVED ON A PATIENT SAMPLE, AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT AFP TESTING ON THE SAME INSTRUMENT, SERIAL SAMPLE DILUTIONS, RAN THE SAMPLE ON ANOTHER ADVIA CENTAUR SYSTEM, AND THE RESULTS WERE ELEVATED. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE AFP TEST METHODS THAT RESULTED LOWER. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT OF PATIENT TREATMENT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULT. MDR 1219913-2018-00007 AND MDR 1219913-2018-00008 WERE FILED FOR RESULTS FROM THE SAME PATIENT FOR A DIFFERENT ADVIA CENTAUR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7208034 ↗
• MalfunctionJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT WAS OBSERVED ON A PATIENT SAMPLE, AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT AFP TESTING ON THE SAME INSTRUMENT, SERIAL SAMPLE DILUTIONS, RAN THE SAMPLE ON ANOTHER ADVIA CENTAUR SYSTEM, AND THE RESULTS WERE ELEVATED. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE AFP TEST METHODS THAT RESULTED LOWER. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT OF PATIENT TREATMENT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULT. MDR 1219913-2018-00007 WAS FILED FOR AN INITIAL RESULT ON THE SAME SYSTEM, AND MDR 1219913-2018-00009 WAS FILED FOR REPEAT ON A DIFFERENT ADVIA CENTAUR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7208028 ↗
• MalfunctionJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT WAS OBSERVED ON A PATIENT SAMPLE, AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT AFP TESTING ON THE SAME INSTRUMENT, SERIAL SAMPLE DILUTIONS, RAN THE SAMPLE ON ANOTHER ADVIA CENTAUR SYSTEM, AND THE RESULTS WERE ELEVATED. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE AFP TEST METHODS THAT RESULTED LOWER. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT OF PATIENT TREATMENT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULT. MDR 1219913-2018-00008 WAS FILED FOR A REPEAT ON THE SAME ADVIA CENTAUR XP SYSTEM, AND MDR 1219913-2018-00009 FOR A REPEAT ON A DIFFERENT ADVIA CENTAUR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7208026 ↗
• MalfunctionJan 11, 2018Adverse 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. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED AS THE PREVIOUS RESULT WAS NEGATIVE. A NEW PATIENT SAMPLE WAS RECEIVED AND TESTED. THE RESULT WAS NEGATIVE. THE INITIAL PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. THE PATIENT'S PRE-EXISTING MEDICAL CONDITION IS HEMOCHROMATOSIS. 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 7183712 ↗
• MalfunctionOct 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR XPT AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS LOW. THE PATIENT SAMPLE WAS TESTED ON ANOTHER ADVIA CENTAUR XPT AND THE RESULT WAS LOW. THE LOW 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 AFP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6939774 ↗
• MalfunctionSep 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED A REPRODUCIBLY, ELEVATED ADVIA CENTAUR XP ALPHA-FETOPROTEIN (AFP) RESULT ON ONE PATIENT SAMPLE COMPARED TO HISTORICAL RESULTS AND AN ALTERNATE METHOD. THE PHYSICIAN QUESTIONED THE RESULT SINCE HISTORICALLY, THE RESULT WAS LOWER. 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 6845673 ↗
• MalfunctionSep 6, 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 AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE NEGATIVE RESULT WAS IN AGREEMENT WITH THE PATIENT'S CLINICAL PICTURE. 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 6845222 ↗
• MalfunctionSep 6, 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 AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE NEGATIVE RESULT WAS IN AGREEMENT WITH THE PATIENT'S CLINICAL PICTURE. 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 6845198 ↗