Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Verigene BC-GN Kit (Catalog number 20-005-021) Recalled by Nanosphere, Inc. Due to There is a specific Extraction Tray lot containing...
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 Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Quantity: 20 extraction trays
Why Was This Recalled?
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
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