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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000 EstradiolTest

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  Class 2 Device Recall IMMULITE 2000 EstradiolTest see related information
Date Initiated by Firm January 13, 2016
Create Date March 24, 2016
Recall Status1 Terminated 3 on January 08, 2018
Recall Number Z-1243-2016
Recall Event ID 73052
510(K)Number K932926  
Product Classification Radioimmunoassay, estradiol - Product Code CHP
Product IMMULITE 2000 EstradiolTest Code E2
Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)
SMN: 10381178, 10702833, 10381177, 10702834

Product Usage:
For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders
Code Information All lots
Recalling Firm/
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact Same
Manufacturer Reason
for Recall
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
FDA Determined
Cause 2
Device Design
Action Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016. The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 9334 units
Distribution Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHP and Original Applicant = DIAGNOSTIC PRODUCTS CORP.