Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Recalled by Nanosphere, Inc. Due to Nanosphere Inc. has recently determined through four customer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nanosphere, Inc. directly.
Affected Products
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 generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Quantity: 1045 extraction trays (840 affected by recall)
Why Was This Recalled?
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nanosphere, Inc.
Nanosphere, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report