Z-2085-2013Class II

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

Name: Z-2085-2013 HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2...
Creator: Life Technologies Corporation
Published: 2013-05-13
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2013-05-13 / Terminated / root cause: manufacturing process

FDA source

Life Technologies Corporation began a recall of 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... on 2013-05-13. FDA classified it as Class II and gives the reason as "Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2085-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Posted: 2013-08-26
Terminated: 2013-08-28
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.
Product code: NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Reason for recall: Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
Root cause tag: manufacturing process
FDA 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 [email protected]. For questions about the details of this product issue, were instructed to contact Technical Support at 800-955-6288 option 4.
Quantity in commerce: 15 kits
Distribution: USA Nationwide Distribution in the states of DE, IA, MN, and NC.
Product codes and lots: Catalog #18081020, Lot #1368760 & Lot #1312093

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2085-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2085-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code NYQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)