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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE

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  Class 2 Device Recall IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE see related information
Date Initiated by Firm December 20, 2013
Date Posted April 25, 2014
Recall Status1 Terminated 3 on May 18, 2018
Recall Number Z-1518-2014
Recall Event ID 67210
510(K)Number K931703  
Product Classification Radioimmunoassay, immunoglobulins (d, e) - Product Code JHR
Product IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd.
For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
Code Information Lots 260 through 275
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-524-2955
Manufacturer Reason
for Recall		 Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Correction Letters (dated 12/20/13) and effectiveness check response forms were sent to customers on 12/20/13 via FedEx to inform them of the issue. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions.
Quantity in Commerce 18,489 units
Distribution Worldwide 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 = JHR and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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