ST AIA-PACK Intact PTH N/ARecalls & reported problems
Tosoh Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14560189210445), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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
Device problems
- Device Ingredient or Reagent Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2021Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
CUSTOMER REPORTED THAT THE QUALITY CONTROL (QC) ON THE INTACT PARATHYROID HORMONE (IPTH) WAS LOW. THIS IS A REPORTABLE EVENT BASED ON DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12791663 ↗
Other Radioimmunoassay, Parathyroid Hormone devices
- VITROS 6802892Ortho Clinical Diagnostics · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall155 reports
- 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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