Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2)
Pending LLM rewrite. Source: FDA_DEVICE Z-0366-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 1. Siemens Material Number (SMN): 10381441
- Catalog Number: L2KPP2
- UDI-DI: 00630414961910
- Lot Number: 385
- ***Expanded 2/18/2026*** 387
- 388
- 389
- 2. Siemens Material Number (SMN): 10381442
- Catalog Number: L2KPP6
- UDI-DI: 00630414961927
Distribution
Distributed nationwide across the United States.
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