Atellica IM TSH3-UL 10995704Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00630414600178), received between May 13, 2020 and Aug 29, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (13 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 13 most recent of 13 reports, 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 ↗
• 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 9, 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 RESULTS FROM TWO ALTERNATE METHODS. 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 15393440 ↗
• MalfunctionSep 9, 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 15393410 ↗
• MalfunctionAug 19, 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 REPEAT TESTING. ON (B)(6) 2022, THE CUSTOMER NOTED CONTROL CHART RESULTS BEYOND EXPECTED RANGE (NEGATIVE BIAS TO RESULTS) AND REPEATED TSH3-UL TESTING FROM THIS PERIOD. SAMPLES FROM TWO PATIENTS PRODUCED REPEAT RESULTS WHICH WERE HIGHER THAN THE INITIAL RESULTS. THE HIGHER RESULTS WERE REPORTED 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 15258554 ↗
• MalfunctionJul 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN(S) QUESTIONED THE LOW TSH RESULT DUE TO DECREASING T4 DOSES AND LOWER FT4 RESULTS. THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST, AND THE TSH RESULT WHEN TESTED AT AN ALTERNATE LABORATORY AND ALTERNATE TEST METHOD RESULTED HIGHER. IT WAS OBSERVED THAT THE PATIENT'S PREVIOUS TSH3 UL TEST HISTORY RESULTS WERE ALSO CONSIDERED TO BE FALSELY DEPRESSED SINCE AUGUST 2019. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249433 ↗
• MalfunctionJul 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN(S) QUESTIONED THE LOW TSH RESULT DUE TO DECREASING T4 DOSES AND LOWER FT4 RESULTS. THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST, AND THE TSH RESULT WHEN TESTED AT AN ALTERNATE LABORATORY AND ALTERNATE TEST METHOD RESULTED HIGHER. IT WAS OBSERVED THAT THE PATIENT'S PREVIOUS TSH3 UL TEST HISTORY RESULTS WERE ALSO CONSIDERED TO BE FALSELY DEPRESSED SINCE AUGUST 2019. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249432 ↗
• MalfunctionJul 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN(S) QUESTIONED THE LOW TSH RESULT DUE TO DECREASING T4 DOSES AND LOWER FT4 RESULTS. THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST, AND THE TSH RESULT WHEN TESTED AT AN ALTERNATE LABORATORY AND ALTERNATE TEST METHOD RESULTED HIGHER. IT WAS OBSERVED THAT THE PATIENT'S PREVIOUS TSH3 UL TEST HISTORY RESULTS WERE ALSO CONSIDERED TO BE FALSELY DEPRESSED SINCE AUGUST 2019. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249410 ↗
• MalfunctionJul 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN(S) QUESTIONED THE LOW TSH RESULT DUE TO DECREASING T4 DOSES AND LOWER FT4 RESULTS. THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST, AND THE TSH RESULT WHEN TESTED AT AN ALTERNATE LABORATORY AND ALTERNATE TEST METHOD RESULTED HIGHER. IT WAS OBSERVED THAT THE PATIENT'S PREVIOUS TSH3 UL TEST HISTORY RESULTS WERE ALSO CONSIDERED TO BE FALSELY DEPRESSED SINCE (B)(6) 2019. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249407 ↗
• MalfunctionJul 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN(S) QUESTIONED THE LOW TSH RESULT DUE TO DECREASING T4 DOSES AND LOWER FT4 RESULTS. THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST, AND THE TSH RESULT WHEN TESTED AT AN ALTERNATE LABORATORY AND ALTERNATE TEST METHOD RESULTED HIGHER. IT WAS OBSERVED THAT THE PATIENT'S PREVIOUS TSH3 UL TEST HISTORY RESULTS WERE ALSO CONSIDERED TO BE FALSELY DEPRESSED SINCE AUGUST 2019. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249387 ↗
• MalfunctionJul 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3 UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN(S) QUESTIONED THE LOW TSH RESULT DUE TO DECREASING T4 DOSES AND LOWER FT4 RESULTS. THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST, AND THE TSH RESULT WHEN TESTED AT AN ALTERNATE LABORATORY AND ALTERNATE TEST METHOD RESULTED HIGHER. IT WAS OBSERVED THAT THE PATIENT'S PREVIOUS TSH3 UL TEST HISTORY RESULTS WERE ALSO CONSIDERED TO BE FALSELY DEPRESSED SINCE (B)(6) 2019. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249345 ↗
• MalfunctionFeb 11, 2021Low Test Results; Low Test Results

  A FALSELY LOW ATELLICA IM TSH3-ULTRA (TSH3-UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER OBSERVED OUT OF RANGE LOW QUALITY CONTROL ISSUES AND PERFORMED REPEAT TSH3-UL TESTING ON ANOTHER ATELLICA IM SYSTEM USING A DIFFERENT REAGENT READYPACK, RESULTING HIGHER. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES WITH THE DIFFERENT REAGENT READYPACK. BOTH REAGENT READYPACKS WERE FROM THE SAME REAGENT LOT 364. THE HIGHER TSH3-UL PATIENT RESULT WAS REPORTED AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317941 ↗
• MalfunctionMay 13, 2020Low Test Results; Low Test Results

  A FALSELY LOW ATELLICA IM TSH3-ULTRA (TSH3-UL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER OBSERVED OUT OF RANGE LOW QUALITY CONTROL ISSUES AND PERFORMED REPEAT TSH3-UL TESTING USING A DIFFERENT REAGENT READYPACK, RESULTING HIGHER. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES WITH THE DIFFERENT REAGENT READYPACK. BOTH REAGENT READYPACKS WERE FROM THE SAME REAGENT LOT 352. THE HIGHER TSH3-UL PATIENT RESULT WAS REPORTED AS THE CORRECT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA (TSH3-UL) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10054056 ↗

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)