FDA Device recall Z-1420-2017
IMMULITE/ IMMULITE 1000 Progesterone
- FDA Device
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of IMMULITE/ IMMULITE 1000 Progesterone by Siemens Healthcare Diagnostics, citing DHEA-S causes falsely elevated progesterone results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1420-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-04 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
DHEA-S causes falsely elevated progesterone results.
Identifiers
| code_info | LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1420-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.