ADVIA Centaur AFPRecalls & reported problems across all models

We found 2 models of ADVIA Centaur AFP by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2017 and Apr 12, 2024 — classified as 38 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 AFP problems

ADVIA Centaur AFP models

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

• ADVIA Centaur® AFP 10309979

  Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
  19 reports
• ADVIA Centaur® AFP 10309980

  Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
  19 reports

Recent ADVIA Centaur AFP adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗

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