Atellica IM PTH 10995621Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Intact Parathyroid Hormone (iPTH) Atellica IM - RGT 190T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414599441), received between Jul 10, 2019 and Aug 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 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.
Reports received per month
Most reported problems
Device problems
- High Test Results2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440902 ↗MalfunctionAug 24, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50405549 ↗MalfunctionJul 10, 2019No Apparent Adverse Event; No Apparent Adverse Event
DISCORDANT ATELLICA IM INTACT PARATHYROID HORMONE (PTH) RESULTS WERE OBTAINED ON 2 DAYS USING REAGENT LOT 22 FOR A TOTAL NUMBER OF 15 DISCORDANT PATIENT SAMPLES. THE INITIAL RESULTS WERE HIGHER THAN THE CUSTOMER EXPECTED. THE SAMPLES WERE REPEATED WITH REAGENT LOT 24, AND THE RESULTS WERE LOWER. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8775875 ↗MalfunctionJul 10, 2019No Apparent Adverse Event; No Apparent Adverse Event
DISCORDANT ATELLICA IM INTACT PARATHYROID HORMONE (PTH) RESULTS WERE OBTAINED ON 2 DAYS USING REAGENT LOT 22 FOR A TOTAL NUMBER OF 15 DISCORDANT PATIENT SAMPLES. THE INITIAL RESULTS WERE HIGHER THAN THE CUSTOMER EXPECTED. THE SAMPLES WERE REPEATED WITH REAGENT LOT 24, AND THE RESULTS WERE LOWER. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8775874 ↗
Other RADIOIMMUNOASSAY, PARATHYROID HORMONE devices
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- Access Intact PTH A16972Beckman Coulter, Inc. · Radioimmunoassay, Parathyroid Hormone2 recalls8 reports
- IMMULITE® 2000 Systems IPT Intact PTH 10381441Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall18 reports
- Future Diagnostics 4K-IPT-00Future Diagnostics Solutions B.V. · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall0 reports
- IMMULITE® 2000 Systems IPT Intact PTH 10381442Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall0 reports
- ADVIA Centaur® iPTH 10492368Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, PARATHYROID HORMONE23 reports
- Elecsys PTH 07251068190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, PARATHYROID HORMONE21 reports
- VITROS 6900052Ortho Clinical Diagnostics · RADIOIMMUNOASSAY, PARATHYROID HORMONE21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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