Z-1514-2020Class II

IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS...

Name: Z-1514-2020 IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-02-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-02-05 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2020-02-05. FDA classified it as Class II and gives the reason as "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-...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1514-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-05
Posted: 2020-02-24
Terminated: 2021-11-18
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.
Product code: CHP Radioimmunoassay, Estradiol
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.
FDA 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 in commerce: 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
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1514-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-18
Z-1514-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-18

Product code CHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)