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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000

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  Class 2 Device Recall IMMULITE 2000 see related information
Date Initiated by Firm April 30, 2012
Date Posted June 02, 2012
Recall Status1 Terminated 3 on March 16, 2017
Recall Number Z-1701-2012
Recall Event ID 61755
510(K)Number K022603  
Product Classification Radioimmunoassay, immunoreactive insulin - Product Code CFP
Product IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange ---

Product Usage:
For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers --- for the quantitative measurement of insulin in serum or heparinized plasma, for the management of diabetes.
Code Information kit lots 312, 313, 314, 315, 316
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Patricia Lazarro
914-524-2955
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
FDA Determined
Cause 2		 Component change control
Action Siemens sent an Urgent Device Recall letter dated April 2012 via fax to affected U.S. customers and an Urgent Field Safety Notice to customers outside the U.S. The letter identified the affected kit lots, reason for voluntary recall, risk to health and actions to be taken by the customer/user. Customers were instructed to discard any inventory of the affected kit lots and complete and return the attached Field Correction Effectiveness Check questionnaire within thirty (30) days to request a no-charge replacement kits. Customers were requested to post this field correction by each IMMULITE system to alert users to the situation. For questions contact your Siemens Technical Solutions Center.
Distribution Worldwide Distribution - US (nationwide)
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 = CFP and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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