ADVIA Centaur® PSA 10310292Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414203003), received between Jul 14, 2017 and Jun 6, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (P950021); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ADVIA CENTAUR PSA RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHILE USING LOT 336. A DEPRESSED RESULT WAS OBSERVED AND NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEAT TESTED ON THE ORIGINAL INSTRUMENT AND ANOTHER DEPRESSED RESULT (NO DETAILS PROVIDED) WAS OBSERVED. FOR TROUBLESHOOTING PURPOSES, THE SAME SAMPLE WAS ALSO REPEAT TESTED ON AN ATELLICA IM ANALYZER WHICH PRODUCED SIMILAR DEPRESSED RESULT (NO DETAILS PROVIDED). THE SAMPLE WAS THEN TESTED USING AN ALTERNATE METHOD AND A HIGHER RESULT WAS OBTAINED. THE HIGHER RESULT WAS CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION AND REPORTED AS CORRECT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED PSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476829 ↗
• MalfunctionDec 2, 2022High Test Results; High Test Results

  A CUSTOMER HAS REPORTED OBSERVATION OF FALSELY-ELEVATED ADVIA CENTAUR XPT PSA RESULTS FOR PATIENTS EXPECTED TO PRODUCE RESULTS BELOW DETECTION LIMIT. THE CUSTOMER INDICATES THAT PSA RESULTS AS HIGH AS 0.3 NG/ML HAVE BEEN SEEN FOR POST-PROSTATECTOMY MALE PATIENTS AND FEMALE PATIENTS, FOR WHOM RESULTS OF <0.01 NG/ML WERE EXPECTED. NO PATIENT DATA WERE PROVIDED. THERE ARE NO REPOPRTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906445 ↗
• MalfunctionNov 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED A NON-REPRODUCIBLE ELEVATED ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY RESULT COMPARED TO REPEAT RESULTS. THE INITIAL RESULT WAS SENT TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE ELEVATED ADVIA CENTAUR XP PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9384313 ↗
• MalfunctionAug 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP PSA RESULT THAT DID NOT MATCH HISTORICAL RESULTS OR THE CLINICAL PICTURE OR THE RESULTS FROM A NEW SAMPLE FROM ONE PATIENT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883711 ↗
• MalfunctionJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED AN ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) RESULT FROM A SAMPLE WHICH WAS DEPRESSED WHEN TESTED NEAT COMPARED TO THE RESULTS FROM DILUTION OF THE SAMPLE AND TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DEPRESSED ADVIA CENTAUR XPT PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426528 ↗
• MalfunctionJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED A LOW ADVIA CENTAUR XPT PSA RESULT THAT WAS HIGHER UPON DILUTION. THE LOW RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7320039 ↗
• MalfunctionDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR XPT PSA TEST RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH DILUTION AND THE RESULT WAS HIGHER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7112168 ↗
• MalfunctionNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE, AND CONSIDERED DISCORDANT COMPARED TO A HIGHER PSA RESULT AT AN ALTERNATE LABORATORY AND TEST METHOD. THE SAME PATIENT SAMPLE HAD BEEN SENT TO THE ALTERNATE LABORATORY FOR FREE PSA, AND THE LABORATORY ALSO PERFORMED TOTAL PSA TESTING THAT RESULTED HIGHER. THE FOLLOWING DAY, THE CUSTOMER PERFORMED DAILY SYSTEM MAINTENANCE AND QUALITY CONTROL (QC) ON THE ADVIA CENTAUR XP SYSTEM. THE ADVIA CENTAUR XP PSA WAS REPEATED USING A DIFFERENT LEFTOVER SAMPLE TUBE FROM THE SAME PATIENT, AND THE RESULT WAS HIGHER COMPARED TO THE INITIAL RESULT. THE SAMPLE TUBE WAS RE-CENTRIFUGED, TESTED IN DUPLICATE, AND THE PSA RESULTS WERE ALSO HIGHER. A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7033305 ↗
• MalfunctionJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN QUESTIONED THE ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS FOR 10 POST-RADICAL PROSTATECTOMY PATIENTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES BASED ON THE ADVIA CENTAUR XP PSA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6713553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950021. One submission often covers many models, so check the product and lot details in each record.

• Z-2742-2016 · Aug 9, 2016 · Terminated
  ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)