Siemens IMMULITE 1000 Estradiol Kits Recalled for Discordant Results
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol 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 the hazard is misdiagnosis leading to delayed or unnecessary treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,267 kits of the IMMULITE 1000 Systems E2 Estradiol product. The recall affects kits with lot numbers beginning with 501 and above, distributed worldwide including the United States and numerous international countries.
The recall is issued 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 lead to the delayed initiation of a potentially beneficial drug and/or the administration of an unnecessary drug in the treatment for 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 tests performed using these kits should consult their healthcare providers to review their results and treatment plans.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,267
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)
- SMN & (UDI) for OUS: 10381132 (00630414966151)
Distribution
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.
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