ADVIA Centaur® eE2 10491445Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00630414574646), received between Jul 16, 2018 and Jul 4, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

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. How this data works · Data updated Oct 13, 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-1024-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ADVIA CENTAUR ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD WHEN USING LOT 104. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER WHICH PRODUCED A SIMILAR ELEVATED RESULT. FOR TROUBLESHOOTING PURPOSES, THE SAME SAMPLE WAS TREATED WITH PEG (POLYETHYLENE GLYCOL 6000) AND RETESTED ON THE ORIGINAL ANALYZER WHICH PRODUCED A LOWER RESULT. THE SAMPLE WAS THEN TESTED ON AN ALTERNATE METHOD WHICH OBTAINED A LOWER RESULT. THIS LOWER RESULT WAS CONSIDERED CORRECT SINCE IT MATCHED THE CLINICAL PICTURE OF THE PATIENT AND WAS ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402685 ↗
• MalfunctionMar 1, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. PRODUCT LOT USED AND DETAILS OF TESTING WERE NOT PROVIDED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461620 ↗
• MalfunctionJul 15, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) NEAT (UNDILUTED) AND ONBOARD (AUTO) DILUTION RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING ON THREE ALTERNATE ESTRADIOL TEST METHODS WITH THE SAME PATIENT SAMPLE (NEAT), ALL RESULTING LOWER. THE LOWER ALTERNATE ESTRADIOL TEST RESULTS AGREED WITH THE CLINICAL PICTURE OF THIS PATIENT. THE LOWER ESTRADIOL RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176466 ↗
• MalfunctionSep 22, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A LOWER RESULT WAS EXPECTED BY THE PHYSICIAN DUE TO ADMINISTERED MEDICATION. THE CUSTOMER SENT THE SAMPLE TO AN ALTERNATE LABORATORY WITH AN ALTERNATE ESTRADIOL TEST METHOD, RESULTING LOWER. THE LOWER ALTERNATE ESTRADIOL TEST RESULT WAS ACCEPTED BY THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED, PRESCRIBED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10570805 ↗
• MalfunctionMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. THE PHYSICIAN SUGGESTED THAT THE SAMPLE BE SENT TO AN ALTERNATE SITE AND TESTED WITH LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY ((LC-MS). THE LC-MS TESTING YIELDED THE EXPECTED RESULT. THE PATIENT HAD A PREVIOUS HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT THAT WAS NOT QUESTIONED. PATIENT IS TAKING FASLODEX. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639896 ↗
• MalfunctionMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICAN QUESTIONED THE RESULT. THE PHYSICIAN SUGGESTED THAT THE SAMPLE BE SENT TO AN ALTERNATE SITE AND TESTED WITH LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY ((LC-MS). THE LC-MS TESTING YIELDED THE EXPECTED RESULT. THE PATIENT HAD A PREVIOUS HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT THAT WAS NOT QUESTIONED. PATIENT IS TAKING FASLODEX. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639895 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS FOR THREE SAMPLES FROM THE SAME PATIENT COMPARED TO CLINICAL EXPECTATIONS AND AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7872351 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS FOR THREE SAMPLES FROM THE SAME PATIENT COMPARED TO CLINICAL EXPECTATIONS AND AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7872342 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS FOR THREE SAMPLES FROM THE SAME PATIENT COMPARED TO CLINICAL EXPECTATIONS AND AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7872338 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS FOR THREE SAMPLES FROM THE SAME PATIENT COMPARED TO CLINICAL EXPECTATIONS AND AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7872337 ↗
• MalfunctionAug 14, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AFTER A REDRAW SAMPLE WAS TESTED IN ANOTHER LABORATORY WITH THE ELECTROCHEMILUMINESCENCE METHOD AND THE RESULT WAS LOW. AFTER THE RESULT WAS QUESTIONED, THE LABORATORY REPEATED THE SAMPLE AGAIN AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS SENT TO A LABORATORY OF SUPPORT AND TESTED. THE RESULT WAS LOW. THE PATIENT IS MENOPAUSAL. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781970 ↗
• MalfunctionJul 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PATIENT. THE PATIENT PROVIDED A PREVIOUS LOWER RESULT FROM AN ALTERNATE METHOD. THE LABORATORY REQUESTED A NEW COLLECTION. THE NEW SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP EE2 ASSAY AND THE RESULT WAS HIGH. THE SAMPLE WAS THEN SENT TO THE LABORATORY OF SUPPORT AND ELECTROCHEMILUMINESCENCE TESTING WAS PERFORMED. THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED AFTER RECENTRIFUGATION, NEAT AND DILUTED, DURING TECHNICAL VISITS, THE RESUTLS WERE HIGH. THE PATIENT IS IN THE POSTMENOPAUSAL PHASE AND DOES NOT TAKE HORMONAL SUPPLEMENTATION. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7691847 ↗
• MalfunctionJul 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PATIENT. THE PATIENT PROVIDED A PREVIOUS LOWER RESULT FROM AN ALTERNATE METHOD. THE LABORATORY REQUESTED A NEW COLLECTION. THE NEW SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP EE2 ASSAY AND THE RESULT WAS HIGH. THE SAMPLE WAS THEN SENT TO THE LABORATORY OF SUPPORT AND ELECTROCHEMILUMINESCENCE TESTING WAS PERFORMED. THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED AFTER RECENTRIFUGATION, NEAT AND DILUTED, DURING TECHNICAL VISITS, THE RESULTS WERE HIGH. THE PATIENT IS IN THE POSTMENOPAUSAL PHASE AND DOES NOT TAKE HORMONAL SUPPLEMENTATION. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7691841 ↗
• MalfunctionJul 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PATIENT. THE PATIENT PROVIDED A PREVIOUS LOWER RESULT FROM AN ALTERNATE METHOD. THE LABORATORY REQUESTED A NEW COLLECTION. THE NEW SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP EE2 ASSAY AND THE RESULT WAS HIGH. THE SAMPLE WAS THEN SENT TO THE LABORATORY OF SUPPORT AND ELECTROCHEMILUMINESCENCE TESTING WAS PERFORMED. THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED AFTER RECENTRIFUGATION, NEAT AND DILUTED, DURING TECHNICAL VISITS, THE RESULTS WERE HIGH. THE PATIENT IS IN THE POSTMENOPAUSAL PHASE AND DOES NOT TAKE HORMONAL SUPPLEMENTATION. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7691838 ↗