Atellica IM TSH3-Ultra II 11208707Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414624525), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Low Test Results; No Apparent Adverse Event

  THE CUSTOMER NOTIFIED SIEMENS OF A DEPRESSED ATELLICA IM TSH3-ULTRA II (TSH3ULII) LOT: 013 RESULT OBTAINED ON A PATIENT SAMPLE THAT IS CONSIDERED DISCORDANT RELATIVE TO AN ALTERNATE METHOD RESULT. THE RESULT IN QUESTION WAS OBTAINED ON (B)(6) 2026 AND WAS REPORTED TO THE PHYSICIAN AND QUESTIONED BASED ON THEIR EXPECTATION. THE CUSTOMER PERFORMED COMPARATIVE TSH TESTING AT A LATER DATE USING 3 ALTERNATE METHODS. IT IS UNKNOWN WHETHER THIS WAS A DIFFERENT SAMPLE DRAW FROM THE PATIENT OR THE SAME SAMPLE USED TO PRODUCE THE RESULT IN QUESTION. ONE OF THE METHODS PRODUCED AN ELEVATED RESULT AND WAS BELIEVED TO BE CORRECT. THE RESULTS OBTAINED ON THE OTHER 2 ALTERNATE METHOD RESULT WERE SIMILAR TO THE INITIAL LOW ATELLICA IM TSH3ULII LOT: 013 RESULT IN QUESTION. HISTORICAL DATA FROM THIS PATIENT WAS PROVIDED TO SIEMENS. NO HISTORICAL RESULT WAS QUESTIONED AT THE TIME OF TESTING. THERE ARE NO REPORTS OF ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614026 ↗