IMMULITE 2000 Progesterone — Class II medical device recall Z-1421-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2017-03-15, distributed nationwide. DHEA-S causes falsely elevated progesterone results.
| Recall number | Z-1421-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2017-01-04 |
| Classified | 2017-03-09 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2019-07-18 |
| Distributed | Nationwide (US) |
| Quantity | 11,963 |
| Lot numbers | 10381170, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470, 471, 472, 474, L2KPW2, L2KPW6 |
| Model numbers | L2KPW2, L2KPW6 |
Product
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
Reason for recall
DHEA-S causes falsely elevated progesterone results.
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-1421-2017. 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.