Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Recalled by Nanosphere, Inc. Due to Nanosphere has received several reports relating to an...
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
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain.
Quantity: 400 units
Why Was This Recalled?
Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
Where Was This Sold?
This product was distributed to 25 states: AZ, CA, FL, GA, IL, IN, IA, KY, MD, MA, MN, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI
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