FDA Device recall Z-2289-2019
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 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-2289-2019 |
| 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 1000 Progesterone, Model LKPW1, SMN Number 10381128
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 | kit lots 0259 and above; UDI: 00630414985732 |
|---|
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-2289-2019%22
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