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U.S. Department of Health and Human Services

Class 2 Device Recall HSV2 Primers

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 Class 2 Device Recall HSV2 Primerssee related information
Date Initiated by FirmMay 13, 2013
Date PostedAugust 26, 2013
Recall Status1 Terminated 3 on August 28, 2013
Recall NumberZ-2085-2013
Recall Event ID 65770
Product Classification Bacteriophage and controls, b. Anthracis lysis - Product Code NYQ
ProductHSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
Code Information Catalog #18081020, Lot #1368760 & Lot #1312093
FEI Number 3003335080
Recalling Firm/
Manufacturer		 Life Technologies Corporation
7335 Executive Way
Frederick MD 21704-8354
For Additional Information ContactNicole Fisher
240-379-4300
Manufacturer Reason
for Recall		Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
FDA Determined
Cause 2		Process design
ActionLife Technologices sent an Urgent Product Recall letter dated May 13, 2013 by certified mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use and dispose all affected units. Customers were advised to complete the Customer Response Sheet included for product/quantities consumed, and send e-mail to techsupport@lifetech.com. For questions about the details of this product issue, were instructed to contact Technical Support at 800-955-6288 option 4.
Quantity in Commerce15 kits
DistributionUSA Nationwide Distribution in the states of DE, IA, MN, and NC.
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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