ADVIA Centaur® BR 10340081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414204772), received between Apr 29, 2022 and Sep 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF ELEVATED ADVIA CENTAUR BR RESULTS WITH LOT # 271 FOR MULTIPLE PATIENT SAMPLES WHICH WERE CONSIDERED DISCORDANT RELATIVE TO REPEAT TESTING. CUSTOMER PROVIDED EXAMPLE DATA FOR ELEVATED ADVIA CENTAUR BR RESULTS FROM 07-AUG-2024. THE INITIAL DISCORDANT ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THEREFORE, THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND OBTAINED MUCH LOWER RESULTS WHEN COMPARED TO THE INITIAL ELEVATED RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT BASED ON THE CLINICAL PICTURE OF THESE PATIENTS. THESE RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). 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 20125733 ↗
• MalfunctionApr 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT CANCER ANTIGEN 27.29 (BR) RESULTS WERE OBTAINED ON 11 PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT AND WERE CONSIDERED DISCORDANT COMPARED TO REPEAT TESTING ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, CANCER ANTIGEN 27.29 (BR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254863 ↗

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-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-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-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-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-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-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-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-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