Atellica IM Anti-Thyroglobulin II (aTgII) 11201761Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414245324), received between Nov 28, 2024 and Nov 28, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULTS WITH THE ATELLICA IM LOT 034 WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THESE PATIENTS WITH THE ALTERNATE ATG METHOD. THE CUSTOMER ALLEGES THAT THIS ISSUE WAS OBSERVED UPON INSTALLATION OF THE ASSAY ON (B)(6) 2024. HOWEVER, THE CUSTOMER HAS REPORTED THIS OBSERVATION OF DISCORDANCE TO SIEMENS RETROSPECTIVELY. THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2024 AND PROVIDED REPRESENTATIVE PATIENT DATA DOCUMENTED IN SECTION B6. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULTS DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804541 ↗
• MalfunctionNov 28, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULT WITH THE ATELLICA IM LOT: 034 WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THE PATIENT WITH THE ALTERNATE ATG METHOD. THE CUSTOMER ALLEGES THAT THIS ISSUE WAS OBSERVED UPON INSTALLATION OF THE ASSAY ON (B)(6) 2024. HOWEVER, THE CUSTOMER HAS REPORTED THIS OBSERVATION OF DISCORDANCE TO SIEMENS RETROSPECTIVELY. THE CUSTOMER CONTACTED SIEMENS ON 07-NOV-2024 AND PROVIDED REPRESENTATIVE PATIENT DATA DOCUMENTED IN SECTION B6. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804539 ↗
• MalfunctionNov 28, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULT WITH THE ATELLICA IM LOT 034 WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THE PATIENT WITH THE ALTERNATE ATG METHOD. THE CUSTOMER ALLEGES THAT THIS ISSUE WAS OBSERVED UPON INSTALLATION OF THE ASSAY ON (B)(6) 2024. HOWEVER, THE CUSTOMER HAS REPORTED THIS OBSERVATION OF DISCORDANCE TO SIEMENS RETROSPECTIVELY. THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2024 AND PROVIDED REPRESENTATIVE PATIENT DATA DOCUMENTED IN SECTION B6. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804536 ↗
• MalfunctionNov 28, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULT WITH THE ATELLICA IM LOT 034 WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THE PATIENT WITH THE ALTERNATE ATG METHOD. THE CUSTOMER ALLEGES THAT THIS ISSUE WAS OBSERVED UPON INSTALLATION OF THE ASSAY ON (B)(6) 2024. HOWEVER, THE CUSTOMER HAS REPORTED THIS OBSERVATION OF DISCORDANCE TO SIEMENS RETROSPECTIVELY. THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2024 AND PROVIDED REPRESENTATIVE PATIENT DATA DOCUMENTED IN SECTION B6. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804519 ↗