FDA Device recall Z-0366-2026
Assay: IMMULITE 2000 Intact PTH
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Assay: IMMULITE 2000 Intact PTH by Siemens Healthcare Diagnostics, citing 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 spe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0366-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-22 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Reason
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.
Identifiers
| code_info | 1. Siemens Material Number (SMN): 10381441; Catalog Number: L2KPP2; UDI-DI: 00630414961910; Lot Number: 385, ***Expande…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; Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0366-2026%22
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