ADVIA Centaur® BR +G 10334837Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414196664), received between Mar 18, 2020 and Mar 1, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K193489, K982680); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ADVIA CENTAUR XP CANCER ANTIGEN 27.29 (BR 27.29 (BR) RESULTS OF >450 U/ML WERE OBTAINED FROM TWO SAMPLES FROM THE SAME PATIENT AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE AUTO DILUTED AND GAVE OVER DILUTION ERRORS. THE TWO SAMPLES WERE REPEATED WITH THE SAME INSTRUMENT WITH MANUAL DILUTIONS, RESULTING LOWER. IT IS UNKNOWN WHICH RESULTS FROM THE, ADVIA CENTAUR XP INSTRUMENT WERE REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ADVIA CENTAUR XP BR 27.29 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638992 ↗
• MalfunctionMar 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ADVIA CENTAUR XP CANCER ANTIGEN 27.29 (BR 27.29 (BR) RESULTS OF >450 U/ML WERE OBTAINED FROM TWO SAMPLES FROM THE SAME PATIENT AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE AUTO DILUTED AND GAVE OVER DILUTION ERRORS. THE TWO SAMPLES WERE REPEATED WITH THE SAME INSTRUMENT WITH MANUAL DILUTIONS, RESULTING LOWER. IT IS UNKNOWN WHICH RESULTS FROM THE, ADVIA CENTAUR XP INSTRUMENT WERE REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ADVIA CENTAUR XP BR 27.29 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638950 ↗
• MalfunctionNov 9, 2020High Test Results; High Test Results

  A FALSELY ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND IT WAS CONSIDERED DISCORDANT COMPARED TO A LOWER RESULT WHEN RETESTED. THE CUSTOMER OBSERVED OUT OF RANGE QUALITY CONTROL (QC) RESULTS THE NEXT MORNING. THE ANCILLARY REAGENT HAD BEEN CHANGED THE PREVIOUS AFTERNOON. A BR ASSAY RECALIBRATION WAS PERFORMED USING NEW REAGENT AND ANCILLARY REAGENTS. QC RESULTS WERE REPEATED AND WITHIN ACCEPTABLE RANGES. THE LABORATORY'S MEDICAL DIRECTOR REVIEWED PATIENT RESULTS, AND A CORRECTED REPORT WAS ISSUED FOR THIS PATIENT. ALL OTHER PREVIOUSLY REPORTED PATIENT RESULTS WERE NOT QUESTIONED BY 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 BR (CA 27.29) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10809549 ↗
• MalfunctionMar 18, 2020High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  A CUSTOMER OBTAINED DISCORDANT HIGH ADVIA CENTAUR XP BR (CA 27.29) RESULTS FOR PATIENT SAMPLES THAT WERE TESTED ON THE SAME DAY. THE RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE PATIENT SAMPLES WERE RETESTED AND THE RETEST RESULTS CORRELATED TO PATIENT HISTORY. CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BR (CA 27.29) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9848963 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193489, K982680. One submission often covers many models, so check the product and lot details in each record.

• Z-2425-2021 · Jul 6, 2021 · Open, Classified
  Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the
• Z-2426-2021 · Jul 6, 2021 · Open, Classified
  Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDT
• Z-2424-2021 · Jul 6, 2021 · Open, Classified
  Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the
• Z-1748-2017 · Mar 8, 2017 · Terminated
  Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantita
• Z-1747-2017 · Mar 8, 2017 · Terminated
  Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitat
• Z-1749-2017 · Mar 8, 2017 · Terminated
  Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the qu
• Z-0512-2013 · Nov 14, 2012 · Terminated
  Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative deter
• Z-0507-2013 · Nov 14, 2012 · Terminated
  Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic
• Z-0162-2013 · Sep 11, 2012 · Terminated
  Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 0