IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH - L2KPP2 (200 Tests)

• • Ongoing Z-0366-2026 FDA Class II ·initiated 22 Sep 2025

  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.

• • Terminated Z-0979-2017 FDA Class II ·initiated 22 Nov 2016

  Siemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirmed that IMMULITE 2000/IMMULITE 2000 XPi Intact PTH kit lot 320 can exhibit an average negative bias of up to -39% at iPTH concentrations <20 pg/mL with serum and EDTA patient samples vs. a reference kit lot.

• • Terminated Z-0724-04 FDA Unclassified (pre-2012) ·initiated 23 Feb 2004

  High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

510(k) Number

K013566 ↗

FDA Product Code

CEW

Models / Variants

LKPP1 (100 Tests)

LKPP5 (500 Tests)

L2KPP2 (200 Tests)

L2KPP6

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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