[pending] Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2)
Pending LLM rewrite. Source: FDA_DEVICE Z-0366-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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