Atellica IM BR 10995478Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00630414598055), received between Oct 16, 2020 and Mar 9, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 275. AN INITIAL ELEVATED BR RESULT WAS OBTAINED FOR A PATIENT SAMPLE IN QUESTION. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RETESTED AT AN ALTERNATE FACILITY, YIELDING A NORMAL RESULT; HOWEVER, THE SPECIFIC VALUE WAS NOT PROVIDED. THE SAMPLE WAS THEN REPEATED ON THE ORIGINAL ANALYZER AND PRODUCED A SIGNIFICANTLY LOWER (NORMAL) RESULT. A NEWLY COLLECTED SAMPLE WAS ALSO TESTED AND GENERATED A RESULT CONSISTENT WITH THE LOWER RESULT, WHICH MATCHED THE PATIENT HISTORY AND WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543664 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ELEVATED ATELLICA IM BR 27.29 (BR) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING BR LOT 272. A LOWER-THAN-EXPECTED ATELLICA IM BR RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. AS THIS RESULT WAS INCONSISTENT WITH PATIENT HISTORY, THE TEST WAS REPEATED USING ANOTHER ATELLICA IM INSTRUMENT. THE REPEAT-TEST RESULT WAS HIGHER, AND CONSISTENT WITH PAST HISTORY. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES DUE TO THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468640 ↗
• MalfunctionFeb 25, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM BR 27.29 (BR) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING BR LOT 272. THE CUSTOMER TESTED 69 ATELLICA IM BR SAMPLES ON (B)(6)2025, AND THE RESULTS WERE QUESTIONED BY PHYSICIANS. THE RESULTS WERE GENERALLY IDENTIFIED AS FALSELY ELEVATED. 10 SAMPLES WITH SUFFICIENT REMAINING VOLUME WERE RE-TESTED ON ANOTHER ATELLICA IM ANALYZER. RESULTS WERE LOWER UPON REPEAT TESTING; 7 OF THESE SAMPLES DEMONSTRATED DIFFERENCES BETWEEN INITIAL AND REPEAT TESTS OF 30% OR GREATER. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES DUE TO THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460884 ↗
• MalfunctionSep 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS DISCORDANT (DEPRESSED) RESULTS OBTAINED WITH ATELLICA IM BR 27.29 (BR) LOT 270. THE SAMPLES WERE RETESTED ON THE SAME INSTRUMENT WITH A DIFFERENT REAGENT PACK OF THE SAME LOT NUMBER AND RESULTS WERE HIGHER AND CONSIDERED CORRECT BASED ON THE CLINICAL HISTORY OF THE PATIENTS. THE INITIAL LOW RESULTS WERE NOT REPORTED. THE RETEST RESULTS WERE REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20222976 ↗
• MalfunctionSep 5, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED BR 27.29 (BR) PATIENT SAMPLE RESULT ON ATELLICA IM ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS MEASURED ON AN ALTERNATE TESTING METHOD (ADVIA CENTAUR) AND THE RESULT WAS LOWER COMPARED TO THE ATELLICA IM RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BR 27.29 (BR) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682479 ↗
• MalfunctionApr 18, 2023High Test Results; High Test Results

  A FALSELY ELEVATED BR 27.29 (BR) (ASSAY FOR CA 27.29) RESULT WAS GENERATED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM 1300 ANALYZER AND RESULTED LOWER THAN THE INITIAL RESULT. ADDITIONALLY, THE PATIENT WAS REDRAWN AND THE SAMPLE WAS PROCESSED ON THE SAME ATELLICA IM 1300 ANALYZER AND THE RESULT WAS LOWER THAN THE INITIAL SAMPLE RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S), AS THE CORRECT RESULT. BOTH THE REPEAT AND REDRAW RESULTS CORRESPONDED TO THE PATIENT'S HISTORICAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761912 ↗
• MalfunctionFeb 25, 2022High Readings; High Readings

  CUSTOMER OBSERVED ELEVATED ATELLICA IM BR 27.29 (BR) RESULTS FROM A SAMPLE THAT WAS CONSIDERED DISCORDANT WITH THE REPLICATE TESTING. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED DISCORDANT BR 27.29 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600478 ↗
• MalfunctionNov 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER OBSERVED AN ELEVATED ATELLICA IM 1600 BR (BR 27.29) RESULT FROM A SAMPLE THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT ON REDRAW. ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BR 27.29 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797596 ↗
• MalfunctionNov 4, 2021High Test Results; High Test Results

  CUSTOMER OBSERVED DISCORDANT ELEVATED ATELLICA IM 1600 BR (BR 27.29) RESULTS FOR TWO PATIENT SAMPLES COMPARED TO REPEAT TESTING AND HISTORICAL RESULTS. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754995 ↗
• MalfunctionNov 4, 2021Low Test Results; Low Test Results

  CUSTOMER OBSERVED A DISCORDANT DEPRESSED ATELLICA IM 1600 BR (BR 27.29) RESULT FOR A PATIENT SAMPLE COMPARED TO INITIAL TESTING OF A DIFFERENT DRAW. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754885 ↗
• MalfunctionOct 16, 2020High Readings; High Readings

  DISCORDANT ELEVATED ATELLICA IM 1600 BR (CA 27.29) RESULTS WERE OBTAINED FOR SIX (6) PATIENT SAMPLES, AS COMPARED TO LOWER RESULTS OBSERVED WHEN THE SAME SAMPLES WERE RE-TESTED USING NEW REAGENTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATELLICA IM 1600 BR (CA 27.29) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693395 ↗

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-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-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-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-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