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U.S. Department of Health and Human Services

Class 2 Device Recall MagNA Pure

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  Class 2 Device Recall MagNA Pure see related information
Date Initiated by Firm August 06, 2004
Date Posted August 17, 2004
Recall Status1 Terminated 3 on October 05, 2005
Recall Number Z-1371-04
Recall Event ID 29671
Product Classification Test, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
Product MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
Code Information All units using software version 3.03.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Technical Service
800-526-1247
Manufacturer Reason
for Recall		 A hardware/software problem will result in low elution volumes and bias sample results for various protocols.
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 8/6/04.
Quantity in Commerce 192
Distribution United States.
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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