Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0979-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: January 18, 2017

Recall Number: Z-0979-2017

Event ID: 75837

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2728 kits (US: 565 kits; OUS: 2163 kits)

Code Information:

Lot Number 320, exp. date 2016/11/30; UDI #s: 0063041496191032020161130 and 0063041496192732020161130

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Chile, Mexico, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Peru, Colombia, Ecuador, Bolivia, Costa Rica, Honduras, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Algeria, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Netherlands, Norway, Pakistan, Panama, Paraguay, Poland, Portugal, Republic Korea, Romania, Russian Fed., Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Jordan, U.A.E., United Kingdom and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated