FDA Device recall Z-2290-2019
IMMULITE 2000 Progesterone
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of IMMULITE 2000 Progesterone by Siemens Healthcare Diagnostics, citing 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 progest….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2290-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-10 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Reason
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.
Identifiers
| code_info | US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2290-2019%22
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