Life Technologies Recalls HSV-2 Primers Due to Amplification Failure
Life Technologies is recalling 15 kits of HSV-2 Primers because they failed to amplify HSV-2 DNA. The products were distributed in Delaware, Iowa, Minnesota, and North Carolina.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure of a diagnostic reagent (failure to amplify DNA) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or functional defects.
Plain-English summary
Life Technologies Corporation is recalling 15 kits of HSV 2 Primers, Catalog #18081020. These products are Analyte Specific Reagents intended for use in clinical laboratories when developing their own diagnostic tests for Herpes Simplex Virus 2 (HSV-2).
The recall was initiated after the firm received complaints that the HSV-2 primers failed to amplify HSV-2 DNA. The affected products are identified by Lot #1368760 and Lot #1312093.
The recalled products were distributed nationwide in the United States, specifically in the states of Delaware, Iowa, Minnesota, and North Carolina. Clinical laboratories should stop using these specific lots and contact Life Technologies Corporation for further instructions.
The recalled product
- 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.
- Manufacturer
- Life Technologies Corporation
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog #18081020
- Lot #1368760 & Lot #1312093
Distribution
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