IMMULITE 2000 Progesterone — Class II medical device recall Z-2290-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-08-28, distributed nationwide. There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low pro
| Recall number | Z-2290-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-07-10 |
| Classified | 2019-08-17 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2024-05-28 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00630414167510, 00630414167718, 00630414961972, 00630414961989 |
| Lot numbers | 510, D510 |
| Model numbers | L2KPW2, L2KPW6 |
Product
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Reason for recall
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
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-2290-2019. 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.