FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2085-2013
- Recalling firm
- Life Technologies Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-05-13
- Posted
- 2013-08-26
- Terminated
- 2013-08-28
- 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.
- Lot, serial or model codes
- Catalog #18081020, Lot #1368760 & Lot #1312093
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NYQ
- Firm FEI
- 3003335080
- Firm city
- Frederick
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28