HSV 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.
This recall has been terminated (originally issued August 26, 2013).
- Company
- Life Technologies Corporation
- Recall Initiated
- May 13, 2013
- Posted
- August 26, 2013
- Terminated
- August 28, 2013
- Recall Number
- Z-2085-2013
- Quantity
- 15 kits
- Firm Location
- Frederick, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
Distribution
USA Nationwide Distribution in the states of DE, IA, MN, and NC.
Lot / Code Info
Catalog #18081020, Lot #1368760 & Lot #1312093
Root Cause
Process design
Action Taken
Life 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.