Terminated

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 diagnosis and treatment of various sexual disorders.

FDA Recall Z-1514-2020 · Posted 2020-02-24

Recalling FirmSiemens Healthcare Diagnostics, Inc.

Recall StatusTerminated

Product CodeCHP

Date Initiated2020-02-05

Date Terminated2021-11-18

Product Quantity6118 kits

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.

Firm Action

An Urgent Medical Device Correction (UMDC) IMC20-01.A.US was sent to US customers and an Urgent Field Safety Notice (UFSN) IMC20-01.A.OUS was sent to OUS customers in February 2020. The UMDC and UFSN advise customers of the potential for high discordant Estradiol results in some samples on the IMMULITE systems. Siemens Healthineers has determined kit lots 501 and above released in July 2018 for the IMMULITE systems are potentially affected. The UMDC instructs US customers to discontinue use of and discard Estradiol kits currently in their inventory. Customers will also be asked to do a look back if the impacted Estradiol kit lots were used to assess the menopausal status of a female while determining therapy for hormone receptor positive advanced or metastatic breast cancer. The UFSN instructs OUS customers to review the letter with their Medical Director to consider if a retrospective review of patient samples is necessary. Customer will also be instructed to not use any current inventory in their laboratory on patient samples used to assess menopausal status while determining therapy for hormone receptor positive advanced or metastatic breast cancer. These samples will need to be tested using an alternate methodology. Customers may continue to use the kits currently in their inventory and report results on other patient populations. Additionally, if a discordant high result for Estradiol is suspected, customers are advised to follow their established internal procedures to investigate the issue.

Root Cause

Under Investigation by firm

Distribution Pattern

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, KR, LB, LT, LV, LY, ME, MK, MX, NL, NO, PA, PE, PH, PK, PL, PS, PT, PY, QA, RO, RU, SA, SE, SK, SL, SV, SY, TH, TJ, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XK, XS, ZA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.