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U.S. Department of Health and Human Services

Class 2 Device Recall IsMeasles IgG Enzyme Immunoassay Test Kit

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  Class 2 Device Recall IsMeasles IgG Enzyme Immunoassay Test Kit see related information
Date Initiated by Firm October 10, 2008
Date Posted January 07, 2009
Recall Status1 Terminated 3 on May 12, 2010
Recall Number Z-0607-2009
Recall Event ID 50162
510(K)Number K974552  
Product Classification Rubeola (measles) virus serological reagents. - Product Code LJB
Product Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.
Code Information Lot number 41108 and 41108B
Recalling Firm/
Manufacturer		 Diamedix Corporation
2140 N. Miami Avenue
Miami FL 33127
For Additional Information Contact Glenn Gerstenfeld
305-324-2314
Manufacturer Reason
for Recall		 Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
FDA Determined
Cause 2		 Other
Action Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.
Quantity in Commerce 974Test Kits
Distribution Worldwide Distribution --- including USA and country of England.
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 = LJB and Original Applicant = DIAMEDIX CORP.
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