Reported Mar 25, 2020 · Terminated
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- IMMULITE 2000 Systems E2 Estradiol Catalog #:
- USL2KE22(D) (200 tests)
- and L2KE26(D) (600 tests) and OUSL2KE22 (200 tests)
- L2KE26 (600 tests) - Product UsageFor 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
- Lot codes and dates
- Manufacturing Lot #: All kit lots beginning 501 and above
- SMN & (UDI) for L2KE22(D) US
10702833 (00630414947907)L2KE26(D) 10702834 (00630414947914)
- SMN & (UDI) for L2KE22 OUS10381178 (00630414966106)
- L2KE2610381177 (00630414966007)
- Amount recalled
- 6118 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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