IMMULITE/ IMMULITE 1000 Progesterone — Class II medical device recall Z-1420-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2017-03-15, distributed nationwide. DHEA-S causes falsely elevated progesterone results.
| Recall number | Z-1420-2017 |
|---|---|
| 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 | 9,076 |
| Lot numbers | 0245, 0246, 0247, 0248, 0249, LKPW1 |
| Model numbers | LKPW1 |
Product
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems 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-1420-2017. 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.