Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles
Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.
What this means for you
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue involves missing components that affect test functionality rather than direct physical injury or death.
Plain-English summary
Nanosphere, Inc. is recalling Verigene BC-GN Test Kits (Catalog number 20-005-021) because a small number of extraction trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs). These particles are required for the DNA extraction process used in the test.
The recall was initiated after the company received four customer complaints regarding the issue. The affected product is the Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), which is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections.
The recall involves 1,045 extraction trays, of which 840 are affected by the recall. The product was distributed nationwide, including in California, Colorado, Iowa, Montana, Ohio, Oklahoma, Oregon, Texas, and Utah. Users should stop using the affected test kits and contact the manufacturer for instructions.
The recalled product
- Product
- Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to ge
- Manufacturer
- Nanosphere, Inc.
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)
- Lot Number: 042914021B
- Expiration Date: 10/26/14
Distribution
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