Z-0979-2017Class II

SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number...

Name: Z-0979-2017 SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-11-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-11-22 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and... on 2016-11-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0979-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2017-01-09
Terminated: 2018-05-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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 code: CEW Radioimmunoassay, Parathyroid Hormone
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.
FDA root cause: Under Investigation by firm
Action: The firm, Siemens, sent an "Urgent Medical Device Recall" letter IMC16-27.A.US (dated 11/22/2016) to its customers on 11/22/2016 via FedEx. Customers Outside the US were sent an "Urgent Field Safety Notice" dated 11/2016. The letter/notice describes the product, problem and actions to be taken. Customers were instructed to discontinue use of and discard the affected kit; review your inventory of these products to determine your laboratorys replacement needs; Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days by fax to the Customer Care Center at (312) 275-7795; and retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 2728 kits (US: 565 kits; OUS: 2163 kits)
Distribution: 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.
Product codes and lots: Lot Number 320, exp. date 2016/11/30; UDI #s: 0063041496191032020161130 and 0063041496192732020161130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0979-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0979-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code CEW

K013566Class IIImmulite Intact Pth, Immulite 2000 Intact Pth, Models Lkpp1 (100 Tests), Lkpp5 (500 Tests), L2kpp2 (200 Tests), L2kpp6Diagnostic Products Corp. / cleared 2001-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)