IMMULITE 2000 Systems E2 Estradiol recallZ-1514-2020 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 5, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1514-2020
- Status
- Terminated
- Initiated by the company
- Feb 5, 2020
- Posted by the FDA
- Feb 24, 2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 6118 kits
- Product code
- CHP
- 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 description
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.
Code information (models, lots, serial numbers)
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).
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- IMMULITE® 2000 Systems E2 Estradiol 10702833Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, ESTRADIOL1 recall34 reports
- IMMULITE® 2000 Systems E2 Estradiol 10702834Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, ESTRADIOL1 recall6 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84947).
- Z-1513-2020 · TerminatedIMMULITE 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 me…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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