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U.S. Department of Health and Human Services

Class 2 Device Recall MagNA Pure LC Total Nucleic Acid

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  Class 2 Device Recall MagNA Pure LC Total Nucleic Acid see related information
Date Initiated by Firm May 14, 2007
Date Posted June 22, 2007
Recall Status1 Terminated 3 on December 17, 2009
Recall Number Z-0956-2007
Recall Event ID 37948
Product Classification Isolation Kit for Total Nucleic Acids - Product Code NPQ
Product MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
Code Information Lots 11962700, exp. 8/31/07; 12030400, exp. 6/30/07; 12071100, exp. 9/30/07; 12125800, exp. 10/31/07; 12214300, exp. 12/31/07; 12360200, exp. 3/31/08; 12426200, exp. 4/3008; 12543600, exp. 5/31/08; 12672500, exp. 5/31/08; 12725300, exp. 6/30/08; 12799800, exp. 7/31/08; 12917900, exp. 8/31/08; 13024000, exp. 9/30/08; 13081700, exp. 9/30/08; 13197600, exp. 12/31/08 and 13266600, exp. 2/28/09.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact Doyia Turner
800-428-2336
Manufacturer Reason
for Recall		 False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.
FDA Determined
Cause 2		 Other
Action Consignees were sent an Urgen Medical Device Correction letter dated 5/14/07 which instructs them to define and establish a lower detection limit, to use UNG to prevent carryover whenever possible, and to confirm low positive results through an independent experiment. A revised device correction letter dated 6/15/07 was subsequently sent to each consignee updating the reason for recall and associated risks.
Quantity in Commerce 4,201
Distribution 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.
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