Siemens Healthcare Diagnostics, Inc.: 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.

Recall number

Z-1514-2020

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

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.

Status

Terminated

Initiated

2020-02-05

Posted

2020-02-24

Terminated

2021-11-18

Reason

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.

Root cause

Under Investigation by 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.

Quantity

6118 kits

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, 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

Lot, serial or model codes

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).

510(k) numbers

not on file

PMA numbers

not on file

Product code

CHP

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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