Reported Nov 5, 2025 · Ongoing
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- AssayIMMULITE 2000 Intact PTH
- Test CodeiPT
- Siemens Material Number (SMN)
(1) 10381441(2) 10381442
- Catalog Number
(1) L2KPP2(2) L2KPP6
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published — 10381441 L2KPP2— — 00630414961910UDI-DI: 00630414961910 — Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389 — Siemens Material Number (SMN): 10381442 L2KPP6— — 00630414961927UDI-DI: 00630414961927 — Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389 - Amount recalled
- 3318 units (169 US, 3149 OUS)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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