HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex

FDA device recall Z-2085-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Life Technologies Corporation

Reason for recall

Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

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.

Root cause

Process design

Status

Terminated

Product code

NYQ

Quantity affected

15 kits

Distribution

USA Nationwide Distribution in the states of DE, IA, MN, and NC.

Date initiated

2013-05-13

Date posted

2013-08-26

Date terminated

2013-08-28

Location

Frederick, MD