Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 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,… |
| Initiated | 2016-11-22 |
| Classified | 2017-01-09 |
| Terminated | 2018-05-25 |
| Recall number | Z-0979-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0979-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75837/
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