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 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.

FDA Recall Z-0979-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.

Recall StatusTerminated

Product CodeCEW

Date Initiated2016-11-22

Date Terminated2018-05-25

Product Quantity2728 kits (US: 565 kits; OUS: 2163 kits)

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.

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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013566IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6Diagnostic Products Corp. · 2001-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.