FDA Device recall Z-1513-2020
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE sy…
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE sy… by Siemens Healthcare Diagnostics, citing due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1513-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-05 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.
Reason
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
Identifiers
| code_info | Lot #: All in date kit lots beginning 501 and above. Code: Siemens Material Number (SMN) & (UDI) for US: 10702832 (0…Lot #: All in date kit lots beginning 501 and above. Code: Siemens Material Number (SMN) & (UDI) for US: 10702832 (00630414947891); SMN & (UDI) for OUS: 10381132 (00630414966151) |
|---|
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-1513-2020%22
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