IMMULITE®/IMMULITE® 1000 Systems iPT Intact PTH 10381399Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414964515), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K013566); they may or may not involve this specific model.

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.

• MalfunctionFeb 27, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED INTACT PARATHYROID HORMONE (IPT) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLES WERE REPEATED 2 TIMES USING THE SAME IMMULITE 2000 XPI. THE FIRST REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED IPT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013566. One submission often covers many models, so check the product and lot details in each record.

• Z-0366-2026 · Sep 22, 2025 · Open, Classified
  Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
• Z-0979-2017 · Nov 22, 2016 · Terminated
  SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L
• Z-0724-04 · Feb 23, 2004 · Terminated
  IMMULITE 2000 Intact PTH kit