ARCHITECT 08K2529Recalls & reported problems
Abbott GmbH · ARCHITECT Intact PTH Reagent Kit · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740156244), received between Sep 15, 2020 and Aug 18, 2021 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Test Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2021High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT INTACT PTH RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=173 PG/ML /PHYSICIAN QUESTIONED THE INITIAL RESULT REPEATED AT LABCORP=54 PG/ML. LABORATORY REFERENCE RANGE FOR IPTH=15 TO 68 PG/ML. THE CUSTOMER PERFORMED COMPARISON STUDY WITH QUEST FOR TROUBLESHOOTING PURPOSE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12338892 ↗MalfunctionSep 15, 2020High Test Results; High Test Results
THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT INTACT PTH RESULT FOR A PATIENT. THE PATIENT SAMPLE GENERATED AN INITIAL RESULT OF 201 PG/ML AND REPEATED A RESULT OF 30 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10537541 ↗
Other RADIOIMMUNOASSAY, PARATHYROID HORMONE devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.