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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 FirmNovember 05, 2004
Date PostedDecember 08, 2004
Recall Status1 Terminated 3 on August 29, 2005
Recall NumberZ-0297-05
Recall Event ID 30483
Product Classification Test, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
ProductMagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
Code Information All systems using software version 3.09.
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-1247
Manufacturer Reason
for Recall		Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.
FDA Determined
Cause 2		Other
ActionConsignees were notified via letter dated 11/5/04, which provides the user with a workaround.
Quantity in Commerce65
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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