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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 Puresee related information
Date Initiated by FirmApril 04, 2006
Date PostedApril 19, 2006
Recall Status1 Terminated 3 on July 03, 2006
Recall NumberZ-0774-06
Recall Event ID 34904
Product Classification Test, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
ProductRoche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-1247
Manufacturer Reason
for Recall		The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around.
Quantity in Commerce251
DistributionNationwide.
Total Product Life CycleTPLC 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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