Atellica IM TSH3-ULRecalls & reported problems across all models
Siemens Healthcare Diagnostics Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Atellica IM TSH3-UL by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between May 13, 2020 and Aug 29, 2023 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (27 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Atellica IM TSH3-UL problems
Device problems
- Low Test Results27
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient1
Atellica IM TSH3-UL models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Atellica IM TSH3-UL 10995703RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE14 reports
- Atellica IM TSH3-UL 10995704RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE13 reports
Recent Atellica IM TSH3-UL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2023Low Test Results; Low Test Results
THE CUSTOMER OBTAINED A DISCORDANT FALSELY DEPRESSED THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL) RESULT FOR A PATIENT SAMPLE, ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER, AND THE RESULT WAS HIGHER COMPARED TO THE INITIAL RESULT. THE HIGHER RESULT WAS CONSIDERED AS CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED TSH3-UL RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17640432 ↗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 ↗MalfunctionJul 10, 2023Low Test Results; Low Test Results
THE CUSTOMER OBTAINED A LOW PATIENT SAMPLE RESULT USING ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL), LOT 415. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), BUT NOT QUESTIONED. THE CUSTOMER RETESTED THE PATIENT SAMPLE WITH A DIFFERENT REAGENT PACK ON THE SAME ANALYZER AND THE RESULT WAS HIGHER AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM TSH3-UL RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17288871 ↗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 ↗
Other Siemens Healthcare Diagnostics Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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