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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 July 17, 2006
Date Posted August 05, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-1373-06
Recall Event ID 35790
Product Classification Test, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
Product Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-262-4911
Manufacturer Reason
for Recall		 If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.
Quantity in Commerce 771 total for recalls Z-1372-1374-06
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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