ADVIA Centaur® PSA 10310293Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00630414202990), received between Nov 29, 2017 and Sep 5, 2019 — classified as 5 malfunctions.

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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ADVIA CENTAUR XP PSA DILUTED VALUES WERE OBTAINED FOR A PATIENT SAMPLE DURING PHYSICAL EXAMINATION. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NORMAL. THE HIGH ADVIA CENTAUR XP PSA DILUTED VALUES WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. A CORRECTED REPORT WAS ISSUED. THE RESULTS FROM THE ALTERNATE METHOD AGREE WITH THE CLINICAL PICTURE OF THE PATIENT. THERE IS NO INDICATION OF A CANCER DIAGNOSIS WITH THIS PATIENT. 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 8964470 ↗
• MalfunctionJul 5, 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 HIGH ADVIA CENTAUR XPT PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED BY THE CUSTOMER ON A PROSTATECTOMY PATIENT. THE PATIENT WAS REDRAWN DUE TO A PREVIOUS ADVIA CENTAUR XPT PSA RESULT ((B)(6) 2018) THAT WAS FALSELY ELEVATED, AND QUESTIONED BY THE PHYSICIAN. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT PSA RESULT. MDR 1219913-2018-00151 WAS FILED PREVIOUSLY FOR A FALSELY ELEVATED RESULT ON THE SAME PATIENT. MDR 1219913-2018-00151 SUPPLEMENTAL REPORT 1 WAS FILED FOR A RESULT CORRECTION, AND ADDITIONAL INFORMATION. MDR 1219913-2018-00151 SUPPLEMENTAL REPORT 2 WAS FILED FOR A CORRECTION AND ADDITIONAL INFORMATION THAT WAS NOT ORIGINALLY PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7848476 ↗
• MalfunctionJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE, AND QUESTIONED BY THE PHYSICIAN. THE PSA RESULT WAS CONSIDERED DISCORDANT COMPARED TO LOWER PSA HISTORICAL RESULTS. THE CUSTOMER PERFORMED REPEAT TESTING OF THE PATIENT SAMPLE, AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7665209 ↗
• MalfunctionJan 29, 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 HIGH ADVIA CENTAUR XPT PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE, AND CONSIDERED DISCORDANT COMPARED TO LOWER PSA ALTERNATE TEST METHOD RESULTS. THE PHYSICIAN QUESTIONED THE RESULT, A DIFFERENT PATIENT SAMPLE WAS CHECKED ON TWO ALTERNATE PSA TEST METHODS, AND THE RESULTS WERE LOWER. THE PATIENT RECEIVED RADIATION TREATMENT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517152 ↗
• MalfunctionNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT HIGH ADVIA CENTAUR XP PSA RESULTS WERE OBTAINED FOR SAMPLES FROM THREE PATIENTS WHEN CORRELATING REAGENT LOT 277 AND 281. 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 7067599 ↗

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)