Agency classClass IIOur severity:High FDA (Devices)·Z-1514-2020·Announced 2020-03-25

Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results

Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for delayed or unnecessary treatment of breast cancer due to misinterpreted test results.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 6,118 kits of IMMULITE 2000 Systems E2 Estradiol test kits. The affected products are used for in vitro diagnostic testing to measure estradiol levels in serum. The recall includes specific catalog numbers and manufacturing lots beginning with 501 and above, distributed worldwide and across numerous US states.

The recall was initiated due to high discordant Estradiol results that potentially affect all patient populations. A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when they are truly post-menopausal. This misinterpretation may result in the delayed initiation of potentially beneficial drugs or the administration of unnecessary drugs in the treatment of hormone receptor positive advanced or metastatic breast cancer.

Healthcare providers and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. Patients who have had estradiol testing using these kits should consult their healthcare provider to review their results and treatment plans.

The recalled product

Product: IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-diagnosis
delayed-treatment
Affected units: 6,118

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

L2KE26: 10381177 (00630414966007).

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

See all →

High
Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
Severe
Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
Severe
Siemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
High
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
Low
Syva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12

Same hazard · mis diagnosis