Recall Z-2085-2013 ยท NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Life Technologies Corporation
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.
| Date | Aug 26, 2013 (initiated May 13, 2013) |
| Status | Terminated |
| Reason | Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. |
| Root cause | Process design |
| Action | 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 |
| Quantity | 15 kits |
| Distribution | USA Nationwide Distribution in the states of DE, IA, MN, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.