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 serum, as an aid in the
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Systems E2 Estradiol test kits due to inaccurate test results. The kits, which come in packages of 200 or 600 tests, were distributed worldwide and in numerous U.S. states. A total of 6,118 kits are affected, specifically those with manufacturing lot numbers beginning with 501 or higher. The problem identified is that the kits can produce falsely elevated estradiol levels, which could cause clinicians to incorrectly classify a patient as pre-menopausal when they are actually post-menopausal. This misclassification may result in delayed or unnecessary treatment for patients with hormone receptor positive advanced or metastatic breast cancer.
The recall potentially affects all patient populations tested with these kits. The source document does not specify a remedy or action for affected consumers to take.
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: 6118 kits Lot/code info: 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 OUS: 10381178 (00630414966106), L2KE26: 10381177 (00630414966007).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.