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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin

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  Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin see related information
Date Initiated by Firm January 31, 2017
Date Posted April 19, 2017
Recall Status1 Terminated 3 on May 24, 2018
Recall Number Z-2166-2017
Recall Event ID 76770
510(K)Number K955440  
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
Product SHBG IMMULITE 2000/IMMULITE 2000 XPi
For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
Code Information Lot Numbers: 1) 357, 2) 358, 3) 360, 4) 361 & 5) 363  Expiration Dates: 1) 2017-01-30, 2) 2017-03-31, 3) 2017-04-30, 4) 2017-05-31 & 5) 2017-06-30  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		 Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8¿C, as published in the Instructions for Use (IFU). Adjustors stored at 2-8C after 14 days may show a bias in patient samples and quality control falling outside of published ranges. Lookback not recommended.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued an Urgent Medical Device Correction (UMDC) to customers using the affected SHBG adjustor lots. Customers were advised to store the affected reconstituted adjustor lots at 2-8C or -20C for up to 14 days, after which they must be discarded. The IMMULITE/IMMULITE 1000 SHBG is not affected by this issue. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.
Quantity in Commerce 9100 kits
Distribution Nationwide Distribution
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 = CDZ and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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