Atellica IM 1300 Analyzer 11066001Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00630414007960), received between Jun 22, 2018 and Sep 30, 2026 — classified as 3 injuries, 185 malfunctions.

The most frequently reported specific device problem is “High Test Results” (95 reports).

6 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-1252-2022 · 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-2027-2021 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Oct 26, 2020Class IITerminated

   Test Definition scanning may reset custom settings to defaults causing falsely low or high results. 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-0473-2021 · 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-0204-2020 · 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-1299-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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-1586-2018 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946588 ↗
• MalfunctionJun 16, 2026High Test Results

  THE CUSTOMER INFORMED SIEMENS THAT A FALSELY ELEVATED NT-PROBNP (PBNPII) PATIENT RESULT WAS OBTAINED ON THE ATELLICA IM 1300 ANALYZER AND REPORTED TO THE PHYSICIANS. THE CUSTOMER USED AN ALTERNATE ATELLICA IM ANALYZER TO PERFORM REPEAT TESTING AND STATED THAT THE REPEAT RESULT WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518111 ↗
• MalfunctionMay 15, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. AN HOUR LATER A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND WAS PROCESSED ON AN ALTERNATE ATELLICA IM 1300 ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND WAS CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY, CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED WITH THE REPAT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182148 ↗
• MalfunctionApr 17, 2026Computer Software Problem

  THE CUSTOMER REPORTED THAT A TROPONIN (TNIH) TEST WAS PERFORMED ON A PATIENT SAMPLE. THE SAMPLE TESTED INITIALLY TRIGGERED AN ALARM STATING "SVC: SIGNAL ERROR (SIGNAL SHAPE ERROR)". THE ALARM WAS NOT TRANSMITTED TO THE DATA MANAGEMENT SOFTWARE (DMS) AND NOT SENT TO THE DMS FOR VALIDATION. IT IS STILL MARKED AS "IN PROGRESS" STATUS IN THE DMS ON AN ATELLICA IM 1300 ANALYZER. THERE WAS THEREFORE A THREE-HOUR DELAY THAT WAS UNAPPARENT TO THE CUSTOMER BEFORE THE DECISION WAS MADE TO DILUTE THE SAMPLE AND OBTAINED TNIH RESULTS TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915602 ↗
• MalfunctionJan 16, 2026Smoking; Noise, Audible

  THE CUSTOMER REPORTED THAT THE TEMPERATURES FOR AN ATELLICA IM 1300 ANALYZER WERE NOT COMING WITHIN THE RANGE. AS A RESULT, THE CUSTOMER RESTARTED THE ANALYZER FROM THE BREAKER. AFTER THE RESTART, THE CUSTOMER HEARD A RATTLING OR GRINDING NOISE, SMELLED A BURNING SMELL, AND OBSERVED SMOKE FROM UNDERNEATH THE TOP COVER OF THE ANALYZER. THE SMOKE WAS COMING FROM AN AREA NEAR LUMINOMETER. THERE WERE NO LEAKS OR VISIBLE FLAMES. NO ONE WAS INJURED, AND NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THIS EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091342 ↗
• MalfunctionJan 7, 2026Mechanical Problem

  THE CUSTOMER REPORTED THAT DURING MANUAL MAINTENANCE OF THE ATELLICA IM 1300 ANALYZER, THE BACK COVER OF THE IMMUNOASSAY MODULE (IM) DID NOT REMAIN OPEN AND HIT THE BACK OF THE OPERATOR¿S HEAD, CAUSING PAIN FOR 2 DAYS. THE OPERATOR VISITED EMPLOYEE HEALTH FOR AN INITIAL EVALUATION, AND THE PHYSICIAN EVALUATED OPERATOR AND VERIFIED THAT OPERATOR DID NOT HAVE A CONCUSSION. THERE WAS NO INJURY BEYOND THE HIT TO THE OPERATOR'S HEAD. IT IS UNKNOWN IF THE OPERATOR REQUIRED MEDICAL INTERVENTION. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: Pain

  MAUDE report 23987838 ↗
• MalfunctionJan 5, 2026High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED 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 23955839 ↗
• MalfunctionDec 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OUT-OF-RANGE QUALITY CONTROL (QC) RESULTS AND AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. DUE TO QC BEING OUT-OF-RANGES, THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ATELLICA IM ANALYZER WHICH PRODUCED A SIGNIFICANTLY LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT, AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S) BASED ON REPEAT TESTING. 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 23732449 ↗
• MalfunctionDec 3, 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 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE PATIENT WAS REDRAWN AND WAS TESTED ON THE SAME ATELLICA IM 1300 ANALYZER. THE REDRAW 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 23704939 ↗
• MalfunctionNov 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER, AND A SIMILAR ELEVATED RESULT WAS OBTAINED. THEN, THE SAMPLE WAS REPEATED TWICE ON AN ALTERNATE ANALYZER, AND LOWER RESULTS WERE OBTAINED, WHICH WERE CONSIDERED CORRECT. THE REPEAT RESULT OF 660 PG/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567710 ↗
• MalfunctionSep 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED ON AN ORIGINAL AND TWO ALTERNATE ATELLICA IM ANALYZERS. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND WERE CONSIDERED CORRECT. THE REPEAT RESULT OF 0.6MIU/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060928 ↗
• MalfunctionSep 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED ON ORIGINAL AND TWO ALTERNATE ATELLICA IM ANALYZERS. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND WERE CONSIDERED CORRECT. THE REPEAT RESULT OF 0.6MIU/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060927 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUS TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS ON MULTIPLE PATIENT SAMPLES WERE OBTAINED ON AN ATELLICA IM 1300 ANALYZER. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND IF THE SAMPLES WERE REPEATED. THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER INFORMATION RELATED TO SAMPLE IDENTIFIERS, PATIENT RESULTS, DATE OF TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060926 ↗
• MalfunctionAug 28, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON TWO ALTERNATE ATELLICA IM ANALYZERS AND ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT¿S HISTORICAL RESULT. THE REPEAT RESULTS WERE CONSIDERED CORRECT, AND THE RESULT OF 18.93 NG/L WAS REPORTED 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 22911024 ↗
• MalfunctionJul 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED RESULTS WITH HIGH-SENSITIVITY TROPONIN I (TNIH) WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ALTERNATE ATELLICA IM 1300 ANALYZER. THE REPEAT RESULTS RECOVERED WITHIN NORMAL RANGE AND MORE CLOSELY MATCHED THE CLINICAL PICTURE. 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 FALSELY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528592 ↗
• MalfunctionJun 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA IM ANALYZER AND OBTAINED A MUCH LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND WAS ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. 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 22356016 ↗
• MalfunctionJun 27, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA IM 1300 ANALYZER (S/N: (B)(6). THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA IM ANALYZER AND OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT SINCE IT MATCHED THE CLINICAL HISTORY OF THE PATIENT AND WAS ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344153 ↗
• MalfunctionJun 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1300 ANALYZER. THE CUSTOMER INDICATED THAT THE SYSTEM WAS RESULTING POSITIVE, BUT SAMPLES WERE NEGATIVE ON REPEAT ON SECOND SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED ON AN ALTERNATE INSTRUMENT AND OBTAINED CORRECT RESULTS. IT IS UNKNOWN WHICH INSTRUMENT WAS USED FOR REPEAT TESTING. IT IS UNKNOWN IF THE CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). 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 22140015 ↗
• MalfunctionMay 28, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED FOLATE (FOL) AND HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS, FOR QUALITY CONTROL (QC) AND PATIENT SAMPLES, WERE OBTAINED ON THE ATELLICA IM 1300 ANALYZER, AND THE RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER USED AN ALTERNATE ANALYZER TO PERFORM REPEAT TESTING, NOTED THAT REPEAT RESULTS RECOVERED AS EXPECTED, MATCHED THE CLINICAL PICTURE, AND STATED THAT CORRECTED REPORTS WERE ISSUED. 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 22101011 ↗
• MalfunctionMay 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED TWICE ON THE ORIGINAL ANALYZER AND ONCE ON AN ALTERNATE ATELLICA IM 1300 ANALYZER. THE REPROCESSED RESULTS MATCHED THE PATIENT¿S CLINICAL PICTURE AND CONSIDERED CORRECT. THE RESULT OF 3.223 NG/L FROM AN ALTERNATE ATELLICA IM 1300 ANALYZER WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042573 ↗
• MalfunctionApr 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON 5 PATIENT SAMPLES ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE INITIAL RESULT OF THE SAMPLE IDENTIFIED AS (B)(6) WAS QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM 1300 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773288 ↗
• MalfunctionMar 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA IM 1300 ANALYZER AND LOWER RESULT WAS OBTAINED WHICH MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661762 ↗
• MalfunctionMar 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ATELLICA IM 1300 ANALYZER. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA IM 1300 ANALYZER AND LOWER RESULTS WERE OBTAINED WHICH MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661743 ↗
• MalfunctionMar 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND ON AN ALTERNATE ATELLICA IM 1300 ANALYZER. ALSO, A NEW SAMPLE DRAWN FROM THE SAME PATIENT WAS PROCESSED ON THE ORIGINAL ANALYZER AND REPEATED ON AN ALTERNATE ATELLICA IM 1300 ANALYZER. THE REPEAT RESULTS AND REDRAWN SAMPLE RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULT, MATCHED THE PATIENT HISTORY, AND WERE CONSIDERED CORRECT. THE REPEAT RESULT FROM THE ORIGINAL ANALYZER WAS REPORTED TO THE PHYSICIAN(S) AS 'LESS THAN 3 NG/L.' 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 21523789 ↗
• MalfunctionFeb 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE CRITICALLY HIGH INITIAL RESULT WAS HELD IN THE ATELLICA DATA MANAGER (ADM) AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON BOTH THE INITIAL AND ALTERNATE ATELLICA IM 1300 ANALYZERS. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULT AND WERE CONSIDERED CORRECT. THE REPEAT RESULT OBTAINED ON AN ALTERNATE ANALYZER WAS REPORTED 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 21466880 ↗

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-1253-2022 · Apr 13, 2022 · Open, Classified
  Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
• 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-2028-2021 · May 13, 2021 · Open, Classified
  Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
• 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-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-0474-2021 · Oct 26, 2020 · Terminated
  Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 1106
• Z-2404-2020 · May 7, 2020 · Open, Classified
  Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
• Z-2405-2020 · May 7, 2020 · Open, Classified
  Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
• Z-0205-2020 · Aug 15, 2019 · Terminated
  Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
• Z-1300-2019 · Mar 7, 2019 · Terminated
  Atellica IM 1600 Analyzer, Material Number 11066000
• 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.