Atellica IM 1600 Analyzer 11066000Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 00630414002026), received between Sep 14, 2018 and May 21, 2026 — classified as 2 injuries, 194 malfunctions.

The most frequently reported specific device problem is “High Test Results” (101 reports).

7 FDA recall records name this device's identifier, 2 still open.

16 other recalls cover devices cleared under the same FDA submission (K151792); 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.

Recalls naming this device

1. Apr 13, 2022Class IIOpen, Classified

   Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

   Z-1253-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 13, 2021Class IIOpen, Classified

   Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

   Z-2028-2021 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Oct 26, 2020Class IITerminated

   Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

   Z-0474-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Aug 15, 2019Class IITerminated

   Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

   Z-0205-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Mar 7, 2019Class IITerminated

   There were multiple issues identified in the system software which required an update.

   Z-1300-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Mar 7, 2019Class IITerminated

   There were multiple issues identified in the system software which required an update.

   Z-1301-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Feb 26, 2018Class IITerminated

   When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

   Z-1588-2018 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 196 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ERRONEOUSLY ELEVATED ENHANCED ESTRADIOL (EE2) RESULTS ON TWO (2) PATIENT SAMPLES WHEN TESTED ON AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON ALTERNATE ATELLICA IM ANALYZERS AND OBTAINED LOWER RESULTS WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239554 ↗
• MalfunctionMay 21, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ERRONEOUSLY ELEVATED ENHANCED ESTRADIOL (EE2) RESULTS ON TWO (2) PATIENT SAMPLES WHEN TESTED ON AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON ALTERNATE ATELLICA IM ANALYZERS AND OBTAINED LOWER RESULTS WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239551 ↗
• MalfunctionApr 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS N TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (NT PROBNP), TOTAL HUMAN CHORIONIC GONADOTROPIN TOTAL HCG (THCG) AND INTACT PARATHYROID HORMONE (PTH) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. 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 NT PROBNP, PTH AND TCCG PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823710 ↗
• MalfunctionMar 17, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620323 ↗
• MalfunctionMar 2, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED CANCER ANTIGEN CA 19 9 (CA 19 9) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULT FROM THE INITIAL ATELLICA IM ANALYZER WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483016 ↗
• MalfunctionFeb 19, 2026High Test Results

  A FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) TEST RESULT WAS OBTAINED FROM AN ATELLICA IM 1600 ANALYZER. THE QUALITY CONTROL (QC) MATERIAL RUN PRIOR TO THE SAMPLE WAS UNACCEPTABLE. IT IS UNKNOWN IF THE INITIAL TEST RESULT WAS RELEASED TO A PHYSICIAN. AN ALTERNATE SAMPLE WAS TESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER. THE TEST RESULT FROM THE ALTERNATE SAMPLE WAS RELEASED TO A PHYSICIAN AS THE CORRECT TEST RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389264 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULTS FROM AN ATELLICA IM 1600 ANALYZER (S/N (B)(6)) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. AFP TEST RESULTS FROM S/N (B)(6) WERE APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULTS WERE RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLES WERE REPEATED AND CORRECTED TEST RESULT REPORTS RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280357 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULTS FROM AN ATELLICA IM 1600 ANALYZER (S/N (B)(6) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. AFP TEST RESULTS FROM S/N (B)(6) WERE APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULTS WERE RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLES WERE REPEATED AND CORRECTED TEST RESULT REPORTS RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279763 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULTS FROM AN ATELLICA IM 1600 ANALYZER (S/N (B)(6) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. AFP TEST RESULTS FROM S/N (B)(6) WERE APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULTS WERE RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLES WERE REPEATED AND CORRECTED TEST RESULT REPORTS RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279739 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULTS FROM AN ATELLICA IM 1600 ANALYZER (S/N (B)(6)) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. AFP TEST RESULTS FROM S/N (B)(6) WERE APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULTS WERE RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLES WERE REPEATED AND CORRECTED TEST RESULT REPORTS RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279605 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULTS FROM AN ATELLICA IM 1600 ANALYZER (S/N: (B)(6) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. AFP TEST RESULTS FROM S/N: (B)(6) WERE APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULTS WERE RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLES WERE REPEATED AND CORRECTED TEST RESULT REPORTS RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279485 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULTS FROM AN ATELLICA IM 1600 ANALYZER (S/N (B)(6) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. AFP TEST RESULTS FROM S/N (B)(6) WERE APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULTS WERE RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLES WERE REPEATED AND CORRECTED TEST RESULT REPORTS RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279296 ↗
• MalfunctionFeb 6, 2026High Test Results

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A DIFFERENCE IN THE ALPHA FETOPROTEIN (AFP) TEST RESULT FROM AN ATELLICA IM 1600 ANALYZER (S/N (B)(6)) VERSUS AN ALTERNATE ATELLICA IM 1600 ANALYZER. THE AFP TEST RESULT FROM S/N (B)(6) WAS APPROXIMATELY 44% HIGHER THAN EXPECTED. THE INITIAL TEST RESULT WAS RELEASED TO A PHYSICIAN. IT IS UNKNOWN IF THE ORIGINAL SAMPLE WAS REPEATED AND A CORRECTED TEST RESULT REPORT RELEASED. THE CUSTOMER INDICATED THAT THE AFP TEST IS BEING USED FOR CANCER SCREENING PURPOSES ONLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279160 ↗
• MalfunctionJan 5, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL PROSTATE-SPECIFIC ANTIGEN (PSA) AND VITAMIN B12 (VB12) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER AFTER EVALUATING THE IMPACT DUE TO AN ERROR IN THE LIQUID RESIDUES. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967669 ↗
• MalfunctionDec 30, 2025Melted; Use of Device Problem; Melted; Use of Device Problem

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPORTED MELTED POWER CORD PLUGS WERE OBSERVED ON AN ATELLICA IM 1600 ANALYZER DUE TO WATER THAT HAD DROPPED ON THE PLUGS. THERE IS NO SAFETY PROTECTION TO CUT OFF THE POWER IN CASE OF A LEAK. THERE WAS VISIBLE DAMAGE TO THE POWER CORD PLUGS AS A RESULT OF THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920861 ↗
• MalfunctionDec 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALPHA FETOPROTEIN (AFP) RESULTS WERE OBTAINED ON 7 PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS 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, FALSELY ELEVATED AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788991 ↗
• MalfunctionDec 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED ENHANCED ESTRADIOL (EE2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON DIFFERENT ALTERNATE ATELLICA IM 1600 ANALYZERS. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS 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 FALSELY ELEVATED EE2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725534 ↗
• MalfunctionNov 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUSLY ELEVATED ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND OBTAINED A LOWER RESULT WHICH WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591195 ↗
• MalfunctionOct 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) PATIENT RESULT WAS OBTAINED ON THE ATELLICA IM 1600 ANALYZER WITH SERIAL NUMBER (B)(6), AND THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING ON AN ALTERNATE ANALYZER AND STATED THAT THE REPEAT RESULT MATCHES THE CLINICAL PICTURE AND IS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374012 ↗
• MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT TUBING WAS DISCONNECTED FROM THE MANIFOLD CONNECTOR LEADING TO ERRONEOUS TEST RESULTS ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE CUSTOMER DID NOT PROVIDE ANALYTE INFORMATION, PATIENT DATA, NOR ADDITIONAL DETAILS FOR THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018323 ↗
• MalfunctionAug 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPEAT RESULT FROM THE ALTERNATE ANALYZER WAS CONSIDERED CORRECT AND REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894910 ↗
• MalfunctionAug 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873148 ↗
• MalfunctionJul 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES, INCLUDING THREE SAMPLES FOR CARCINOEMBRYONIC ANTIGEN (CEA) AND ONE SAMPLE EACH FOR CANCER ANTIGEN 19-9 (CA 19-9) AND ALPHA FETOPROTEIN (AFP) ON AN ATELLICA IM 1600 ANALYZER. FOR SAMPLE IDENTIFIER (B)(6), THE ERRONEOUS RESULTS WERE OBTAINED FOR BOTH CEA AND CA 19-9 ASSAYS. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN WHETHER THE RESULTS WERE QUESTIONED. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIANS. IT IS UNKNOWN IF THERE ARE ANY KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA, CA 19-9, AND AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573830 ↗
• MalfunctionJul 17, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT ERRONEOUS NON-REACTIVE (NEGATIVE) ATELLICA IM ANTIBODIES TO HEPATITIS C VIRUS (AHCV) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. SAMPLE IDENTIFIER (B)(6) WAS REPEATED THRICE ON THE ORIGINAL ATELLICA IM 1600 ANALYZER AND OBTAINED NON-REACTIVE RESULTS. FOR TROUBLESHOOTING PURPOSES, THE SAMPLES WERE RETESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER AND OBTAINED NON-REACTIVE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE TEST METHOD AND OBTAINED REACTIVE RESULTS WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529025 ↗
• MalfunctionJul 17, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT AN ERRONEOUS NON-REACTIVE (NEGATIVE) ATELLICA IM ANTIBODIES TO HEPATITIS C VIRUS (AHCV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS RETESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER AND OBTAINED A NON-REACTIVE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE TEST METHOD AND OBTAINED A REACTIVE RESULT WHICH WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529003 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151792. One submission often covers many models, so check the product and lot details in each record.

• Z-1252-2022 · Apr 13, 2022 · Open, Classified
  Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
• Z-0125-2022 · Sep 28, 2021 · Open, Classified
  Atellica IM 1600 Analyzer, SMN 11066000
• Z-0124-2022 · Sep 28, 2021 · Open, Classified
  Atellica IM 1300 Analyzer, SMN 11066001
• Z-2027-2021 · May 13, 2021 · Open, Classified
  Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
• Z-0862-2021 · Dec 2, 2020 · Terminated
  Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and qua
• Z-0863-2021 · Dec 2, 2020 · Terminated
  Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and qua
• Z-0473-2021 · Oct 26, 2020 · Terminated
  Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 1106
• Z-2405-2020 · May 7, 2020 · Open, Classified
  Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
• Z-2404-2020 · May 7, 2020 · Open, Classified
  Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
• Z-0204-2020 · Aug 15, 2019 · Terminated
  Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
• Z-1299-2019 · Mar 7, 2019 · Terminated
  Atellica IM 1300 Analyzer, Material Number 11066001
• Z-0781-2019 · Sep 26, 2018 · Terminated
  Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of
• Z-0780-2019 · Sep 26, 2018 · Terminated
  Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component sy
• Z-0192-2019 · Jun 29, 2018 · Terminated
  Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
• Z-0193-2019 · Jun 29, 2018 · Terminated
  Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

…and 1 more.