IMMULITE® Systems PTH CONTROL Intact PTH 10385354Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414953236), received between Sep 8, 2017 and Sep 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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.

• MalfunctionSep 8, 2017Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THE CUSTOMER REPORTED THAT THEIR QUALITY CONTROL WAS OUT OF RANGE WHEN RUNNING TURBO INTACT PARATHYROID HORMONE (TURBO IPTH) ASSAY ON AN IMMULITE 1000 INSTRUMENT, WHEN USING REAGENT LOT 241 AND QUALITY CONTROL KIT LOT 060. THE INTRA OPERATIVE SURGERIES FOR SEVEN PATIENTS WERE DELAYED AS THE SAMPLE TESTING COULD NOT BE PERFORMED DUE TO QUALITY CONTROL BEING OUT OF RANGE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO RESCHEDULING OF THE SURGERIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851220 ↗

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