Atellica IM TSH3-UL 10995703Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00630414600161), received between Jun 3, 2021 and Aug 18, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K150403); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT THAT WAS CONSIDERED DISCORDANT COMPARED TO REPEAT TESTING. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHETHER THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571411 ↗
• MalfunctionSep 13, 2022Low Test Results; Low Test Results

  A DISCORDANT, DEPRESSED THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER COMPARED TO THE RESULT FROM AN ALTERNATE METHOD. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TSH3-UL PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410946 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406188 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406183 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406156 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406149 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED TWO INSTANCES WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406139 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406131 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406121 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED TWO INSTANCES WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406115 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406107 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED TWO INSTANCES WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406078 ↗
• MalfunctionSep 12, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER HAS OBSERVED A CASE WHERE THE ATELLICA IM TSH3-UL RESULT IS BELOW THE ASSAY'S MEASURING INTERVAL (<0.008 MIU/L), BUT TESTING USING AN ALTERNATE METHOD PRODUCED A HIGHER RESULT. THE ALTERNATE-METHOD RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION, AND WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, AND NO REPORTS OF MODIFICATION OF TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406076 ↗
• MalfunctionJun 3, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ATELLICA IM 1300 (S/N: (B)(4)) INSTRUMENT. THE FALSELY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, GENERATING HIGHER RESULTS WHICH WERE REPORTED TO AND ACCEPTED BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TSH3 UL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929516 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150403. One submission often covers many models, so check the product and lot details in each record.

• Z-2054-2018 · Dec 18, 2017 · Open, Classified
  ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)