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.
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Systems E2 Estradiol test kits due to inaccurate results that produce falsely elevated estradiol levels. The affected kits include catalog numbers US: LKE21(D) and OUS: LKE21, with lot numbers beginning 501 and above. Approximately 2,267 kits have been distributed worldwide, including to numerous U.S. states and international countries.
The inaccurate test results could cause doctors to misclassify post-menopausal patients as pre-menopausal, potentially leading to delayed treatment with beneficial drugs or administration of unnecessary medications for hormone receptor positive advanced or metastatic breast cancer. The recall notice does not specify what affected consumers or healthcare providers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, MI, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI. SC, TN, TX, UT, VA, WA, WI, WY, and countries of AE, AF, AL, AO, AR, AT, AU, AZ, BD, BE, BO, BG, BH, BR, CA, CH, CO, CL, CN, CO, CR, CY, DE, DO, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IN, IR, IS, IT, IQ, JO, KE, Quantity: 2267 kits Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.