IMMULITE® 2000 Systems IPT Intact PTH 10381442Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Sep 22, 2025Class IIOpen, Classified

   The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

   Z-0366-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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-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