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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 1000 Estradiol Test

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 Class 2 Device Recall IMMULITE 1000 Estradiol Testsee related information
Date Initiated by FirmJanuary 13, 2016
Create DateMarch 24, 2016
Recall Status1 Terminated 3 on January 08, 2018
Recall NumberZ-1242-2016
Recall Event ID 73052
510(K)NumberK932926 
Product Classification Radioimmunoassay, estradiol - Product Code CHP
ProductIMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders
Code Information All lots
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactSame
508-668-5000
Manufacturer Reason
for Recall		The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.
FDA Determined
Cause 2		Device Design
ActionSiemens 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 Commerce9251 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = CHP
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