ADVIA Centaur® eE2 10490889Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414573342), received between Jul 7, 2017 and Apr 19, 2019 — classified as 3 injuries, 5 malfunctions.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 3, 2022Open, Classified

   Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

   Z-1023-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT A PATIENT SAMPLE RESULTED HIGHER THAN EXPECTED WHEN TESTED WITH THE ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) ASSAY. INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED WITH A SIMILAR RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XPT EE2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531183 ↗
• MalfunctionApr 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT A PATIENT SAMPLE RESULTED HIGHER THAN EXPECTED WHEN TESTED WITH THE ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) ASSAY. INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED WITH A SIMILAR RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XPT EE2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531182 ↗
• MalfunctionOct 9, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) PATIENT RESULTS WERE OBSERVED BY THE CUSTOMER, AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE ELEVATED RESULTS DID NOT FIT PRE-TESTING RESULTS, AND THE SAME PATIENT SAMPLE WAS RUN ON AN ALTERNATE ESTRADIOL TEST METHOD AT ANOTHER LABORATORY. THE ESTRADIOL RESULT WAS LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) RESULT. MDR 1219913-2017-00249 WAS FILED FOR THE SAME PATIENT FOR INITIAL TESTING PERFORMED ON A DIFFERENT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7947129 ↗
• MalfunctionOct 9, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) PATIENT RESULTS WERE OBSERVED BY THE CUSTOMER, AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE ELEVATED RESULTS DID NOT FIT PRE-TESTING RESULTS, AND THE SAME PATIENT SAMPLE WAS RUN ON AN ALTERNATE ESTRADIOL TEST METHOD AT ANOTHER LABORATORY. THE ESTRADIOL RESULT WAS LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ADVIA CENTAUR XPT ENHANCED ESTRADIOL (EE2) RESULT. MDR 1219913-2017-00252 WAS FILED FOR THE SAME PATIENT FOR TESTING PERFORMED ON A DIFFERENT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7947047 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS WERE QUESTIONED ON SAMPLES FROM TWO PATIENTS WHEN THE CUSTOMER RECEIVED URGENT MEDICAL DEVICE RECALL (UMDR) CC-17.15.A.US DATED (B)(6) 2017. THE CUSTOMER SAID TWO CLINICIANS CALLED HIM ABOUT PRODUCT NOT RELATED TO THE RECALL AND WERE CONCERNED ABOUT THE ELEVATED ESTRADIOL LEVELS REPORTED AND WERE CONCERNED OVER THE TWO PATIENTS WHO HAD EE2 RUN AT THIS SITE. BOTH PATIENTS WERE BREAST CANCER PATIENTS AND HAD OOPHORECTOMIES. IT IS UNCLEAR WHETHER THE OOPHORECTOMIES WERE BASED SOLELY OR AT ALL ON THE EE2 RESULT. THE PATIENTS WERE UNDERGOING LUPRON THERAPY. EACH PATIENT HAD LOW FSH LEVELS CONSISTENT WITH LUPRON EFFECT. THE ESTRADIOL AND FSH LEVELS ARE CHECKED ON THESE PATIENTS TO ENSURE THAT THE LUPRON THERAPY IS ACHIEVING ADEQUATE OVARIAN FUNCTION SUPPRESSION. THERE WAS NO CLINICAL INDICATION FOR ULTRASOUND. ACCORDING TO THE CLINICIANS, THE ELEVATED ESTRADIOL LEVELS SUGGESTED THAT ADEQUATE OVARIAN FUNCTION SUPPRESSION WAS NOT BEING ACHIEVED WITH LUPRON THERAPY. BILATERAL OOPHORECTOMY WAS PURSUED. ACCORDING TO THE CLINICIANS, THESE PATIENTS ARE EXPECTED TO HAVE UNMEASURABLE ESTRADIOL LEVELS ON LUPRON AND AROMATASE INHIBITOR THERAPY. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811347 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS WERE QUESTIONED ON SAMPLES FROM TWO PATIENTS WHEN THE CUSTOMER RECEIVED URGENT MEDICAL DEVICE RECALL (UMDR) CC-17.15.A.US DATED JUNE 7, 2017. THE CUSTOMER SAID TWO CLINICIANS CALLED HIM ABOUT PRODUCT NOT RELATED TO THE RECALL AND WERE CONCERNED ABOUT THE ELEVATED ESTRADIOL LEVELS REPORTED AND WERE CONCERNED OVER THE TWO PATIENTS WHO HAD EE2 RUN AT THIS SITE. BOTH PATIENTS WERE BREAST CANCER PATIENTS AND HAD OOPHORECTOMIES. IT IS UNCLEAR WHETHER THE OOPHORECTOMIES WERE BASED SOLELY OR AT ALL ON THE EE2 RESULT. THE PATIENTS WERE UNDERGOING LUPRON THERAPY. EACH PATIENT HAD LOW FSH LEVELS CONSISTENT WITH LUPRON EFFECT. THE ESTRADIOL AND FSH LEVELS ARE CHECKED ON THESE PATIENTS TO ENSURE THAT THE LUPRON THERAPY IS ACHIEVING ADEQUATE OVARIAN FUNCTION SUPPRESSION. THERE WAS NO CLINICAL INDICATION FOR ULTRASOUND. ACCORDING TO THE CLINICIANS, THE ELEVATED ESTRADIOL LEVELS SUGGESTED THAT ADEQUATE OVARIAN FUNCTION SUPPRESSION WAS NOT BEING ACHIEVED WITH LUPRON THERAPY. BILATERAL OOPHORECTOMY WAS PURSUED. ACCORDING TO THE CLINICIANS, THESE PATIENTS ARE EXPECTED TO HAVE UNMEASURABLE ESTRADIOL LEVELS ON LUPRON AND AROMATASE INHIBITOR THERAPY. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811344 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS WERE QUESTIONED ON SAMPLES FROM TWO PATIENTS WHEN THE CUSTOMER RECEIVED URGENT MEDICAL DEVICE RECALL (UMDR) CC-17.15.A.US DATED JUNE 7, 2017. THE CUSTOMER SAID TWO CLINICIANS CALLED HIM ABOUT PRODUCT NOT RELATED TO THE RECALL AND WERE CONCERNED ABOUT THE ELEVATED ESTRADIOL LEVELS REPORTED AND WERE CONCERNED OVER THE TWO PATIENTS WHO HAD EE2 RUN AT THIS SITE. BOTH PATIENTS WERE BREAST CANCER PATIENTS AND HAD OOPHORECTOMIES. IT IS UNCLEAR WHETHER THE OOPHORECTOMIES WERE BASED SOLELY OR AT ALL ON THE EE2 RESULT. THE PATIENTS WERE UNDERGOING LUPRON THERAPY. EACH PATIENT HAD LOW FSH LEVELS CONSISTENT WITH LUPRON EFFECT. THE ESTRADIOL AND FSH LEVELS ARE CHECKED ON THESE PATIENTS TO ENSURE THAT THE LUPRON THERAPY IS ACHIEVING ADEQUATE OVARIAN FUNCTION SUPPRESSION. THERE WAS NO CLINICAL INDICATION FOR ULTRASOUND. ACCORDING TO THE CLINICIANS, THE ELEVATED ESTRADIOL LEVELS SUGGESTED THAT ADEQUATE OVARIAN FUNCTION SUPPRESSION WAS NOT BEING ACHIEVED WITH LUPRON THERAPY. BILATERAL OOPHORECTOMY WAS PURSUED. ACCORDING TO THE CLINICIANS, THESE PATIENTS ARE EXPECTED TO HAVE UNMEASURABLE ESTRADIOL LEVELS ON LUPRON AND AROMATASE INHIBITOR THERAPY. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811328 ↗
• MalfunctionJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBSERVED A HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) PATIENT RESULTS THAT WERE CONSIDERED DISCORDANT COMPARED TO A LOWER ESTRADIOL RESULT ON AN ALTERNATE TEST METHOD. THE PATIENT HAS BEEN MONITORED FOR ESTRADIOL SINCE (B)(6) 2016, IS TAKING ANASTRAZOLE, AND THE PHYSICIAN WAS EXPECTING LOWER RESULTS. THE PATIENT WAS TESTED EIGHT DAYS LATER FOR ESTRADIOL ON THE ADVIA CENTAUR XP, THE FIRST, SECOND AND THIRD ALTERNATE TEST METHODS. THE ADVIA CENTAUR XP ESTRADIOL RESULTS WERE CONSIDERED TO BE SIMILAR COMPARED TO ONE OF THE ALTERNATE TEST METHODS, AND HIGHER COMPARED TO THE OTHER TWO. IT IS UNKNOWN IF THE TEST SAMPLE WAS A NEW BLOOD DRAW OR THE SAMPLE FROM (B)(6) 2017. THERE WAS NO REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6694982 ↗