# FDA recall Z-1513-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-02-05.

## Product

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.

## 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, 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

## Key facts

- **Recall number:** Z-1513-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-05
- **Report date:** 2020-03-25
- **Termination date:** 2021-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2020

## Citation

> AI Analytics. FDA recall Z-1513-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1513-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*