Assay: IMMULITE 2000 Intact PTH — Class II medical device recall Z-0366-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-11-05, distributed nationwide. The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or
| Recall number | Z-0366-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2025-09-22 |
| Classified | 2025-10-27 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BG, BO, BR, CA, CL, CN, CO, CY, CZ, DE, EC, EG, ES, FR, GR, GT, HN, HU, IL, IN, IR, IT, KW, LB, LV, MX, NL, NP, PE, PK, PL, PT, PY, QA, RO, RS, SI, SK, TN, TR, TW, UA, UY, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414961910, 00630414961927 |
| Lot numbers | 385 |
| Model numbers | L2KPP2, L2KPP6 |
Product
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0366-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.