ADVIA Centaur® BR +G 10333349Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414196657), received between Mar 28, 2019 and May 14, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULT FOR A PATIENT SAMPLE COMPARED TO HISTORICAL RESULTS AND THE CLINICAL PICTURE. A SECOND SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS ALSO ELEVATED. THE SECOND SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND WAS LOWER AND MATCHED THE CLINICAL PICTURE. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826979 ↗
• MalfunctionMay 14, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULT FOR A PATIENT SAMPLE COMPARED TO HISTORICAL RESULTS AND THE CLINICAL PICTURE. A SECOND SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS ALSO ELEVATED. THE SECOND SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND WAS LOWER AND MATCHED THE CLINICAL PICTURE. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826976 ↗
• MalfunctionJun 23, 2020High Test Results; High Test Results

  FALSELY ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO LOWER RESULTS WHEN TESTED WITH NEW SAMPLES. THE ORIGINAL SAMPLES HAD BEEN PREVIOUSLY TESTED AT AN ALTERNATE SITE (CLIENT), RESULTING LOWER. THE DISCORDANT, BR RESULTS WERE NOT REPORTED TO THE PROVIDER(S). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP BR (CA 27.29) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183487 ↗
• MalfunctionOct 4, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY HIGH CANCER ANTIGENS BR (CA27.29) PATIENT RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). REPEAT SAMPLE WAS REPEATED THREE TIMES ON THE SAME INSTRUMENT, ALL RESULTING IN A LOWER VALUE. THE REPEAT RESULTS WERE CONSIDERED THE CORRECT RESULTS AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158127 ↗
• MalfunctionMar 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY HIGH PATIENT SAMPLE RESULT OF >450 U/ML WAS OBTAINED ON (B)(6) 2019 USING ADVIA CENTAUR XP BR ((B)(4)) ASSAY WITH REAGENT LOT 047234 AND CALIBRATOR LOT CG40. THE CUSTOMER REPEATED TESTING OF THE SAMPLE WITH X10 AND X20 AUTOMATIC ONBOARD DILUTIONS AND OBTAINED OVER-DILUTION ERRORS AND REPEATED WITH A MANUAL DILUTION, AT 1:5 WHICH RESULTED AT 34.5 U/ML. REPEAT TESTING WAS PERFORMED ON (B)(6) 2019 RESULTING IN AN ADDITIONAL HIGH NEAT RESULT AND OVER-DILUTION ERROR. THE SAMPLE WAS LATER RUN ON THE SAME DAY ON A DIFFERENT ADVIA CENTAUR AND RESULTED AT 7.24 U/ML WITHOUT OVER-DILUTION ERRORS. FALSE HIGH RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462176 ↗
• MalfunctionMar 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY HIGH PATIENT SAMPLE RESULT OF >450 U/ML WAS OBTAINED ON (B)(6) 2019 USING ADVIA CENTAUR XP BR (CA 27.29) ASSAY WITH REAGENT LOT 047234 AND CALIBRATOR LOT CG40. THE CUSTOMER REPEATED TESTING OF THE SAMPLE WITH X10 AND X20 AUTOMATIC ONBOARD DILUTIONS AND OBTAINED OVER-DILUTION ERRORS AND REPEATED WITH A MANUAL DILUTION, AT 1:5 WHICH RESULTED AT 34.5 U/ML. REPEAT TESTING WAS PERFORMED ON (B)(6) 2019 RESULTING IN AN ADDITIONAL HIGH NEAT RESULT AND OVER-DILUTION ERROR. THE SAMPLE WAS LATER RUN ON THE SAME DAY ON A DIFFERENT ADVIA CENTAUR AND RESULTED AT 7.24 U/ML WITHOUT OVER-DILUTION ERRORS. FALSE HIGH RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462167 ↗

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-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-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-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-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-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-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