Atellica IM BR 10995477Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414598048), received between Jul 10, 2020 and Feb 1, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022High Test Results; High Test Results

  A CUSTOMER REPORTED OBSERVATION OF A DISCORDANT, ELEVATED ATELLICA IM BR 27.29 (BR) RESULT FOR ONE PATIENT. AN INITIAL ELEVATED RESULT WAS QUESTIONED BY THE PHYSICIAN, AND REPEAT-TESTING OF THE SAME SAMPLE WAS PERFORMED USING THE SAME METHOD ON THE SAME INSTRUMENT. THE FIRST REPEAT RESULT OBTAINED WAS LOWER, AND CONSIDERED CORRECT; THIS RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM BR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417457 ↗
• MalfunctionFeb 1, 2022High Test Results; High Test Results

  A CUSTOMER REPORTED OBSERVATION OF A DISCORDANT, ELEVATED ATELLICA IM BR 27.29 (BR) RESULT. AN INITIAL ELEVATED RESULT WAS QUESTIONED BY THE PHYSICIAN, AND REPEAT-TESTING OF THE SAME SAMPLE WAS PERFORMED USING THE SAME METHOD ON A DIFFERENT INSTRUMENT. THE FIRST REPEAT RESULT OBTAINED WAS LOWER, AND CONSIDERED CORRECT; THIS RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM BR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417363 ↗
• MalfunctionJan 6, 2022Low Test Results; Low Test Results

  CUSTOMER OBSERVED A DISCORDANT DEPRESSED ATELLICA IM 1600 BR (BR 27.29) RESULT FOR A PATIENT SAMPLE COMPARED TO OTHER REPLICATES. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. A CT SCAN WAS PERFORMED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED BR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174704 ↗
• MalfunctionJan 6, 2022Low Test Results; Low Test Results

  CUSTOMER OBSERVED A DISCORDANT DEPRESSED ATELLICA IM 1600 BR (BR 27.29) RESULT FOR A PATIENT SAMPLE COMPARED TO OTHER REPLICATES. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. A CT SCAN WAS PERFORMED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BR DEPRESSED RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174702 ↗
• MalfunctionAug 20, 2021High Test Results; High Test Results

  FALSELY ELEVATED, ATELLICA IM BR 27.29 (BR) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES AS COMPARED TO LOWER RESULTS OBSERVED WHEN THE SAME SAMPLES WERE RE-TESTED WITH AN ALTERNATE ATELLICA IM SYSTEM. THE CUSTOMER HAD OBSERVED ERRATIC/HIGH QUALITY CONTROL (QC) RESULTS AND PERFORMED A PATIENT RESULT LOOKBACK VERIFICATION. THE LOWER REPEAT BR RESULTS ON THE ALTERNATE ATELLICA IM SYSTEM WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ATELLICA IM BR 27.29 (BR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350713 ↗
• MalfunctionMay 5, 2021High Test Results; High Test Results

  FALSELY ELEVATED, ATELLICA IM BR 27.29 (BR) RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES AS COMPARED TO LOWER RESULTS OBSERVED WHEN THE SAME SAMPLES WERE RE-TESTED USING A NEW REAGENT READYPACK. THE CUSTOMER'S QUALITY CONTROL (QC) RESULTS WERE OBSERVED TO BE OUT OF RANGE AT THE TIME OF THE INCIDENT AND REPEAT TESTING WAS PERFORMED AFTER ACCEPTABLE QC RESULTS WERE OBTAINED. THE LOWER REPEAT BR RESULTS WERE REPORTED AS THE CORRECTED RESULTS TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ATELLICA IM BR 27.29 (BR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779263 ↗
• MalfunctionJul 10, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A BIAS BETWEEN TWO LOTS OF ATELLICA IM 1600 BR 27.29 (BR) REAGENTS ON SIX PATIENT SAMPLES. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED DUE TO THE BIAS BETWEEN ATELLICA 1600 BR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10258139 ↗
• MalfunctionJul 10, 2020High Test Results; High Test Results

  ON (B)(6) 2020, TWO DISCORDANT ELEVATED RESULTS WERE OBSERVED USING THE BR 27.29 ASSAY ON THE ATELLICA IM 1300 ANALYZER, WHEN COMPARED TO THE BR 27.29 ASSAY ON THE ADVIA CENTAUR XP. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE ELEVATED ATELLICA IM 1300 BR 27.29 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10257263 ↗

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-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