FDAFDA · Food and drugs·Recall number Z-2681-2014
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.
Published October 1, 2014 · Recall initiated: October 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nanosphere, Inc.
- Distributor
- Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
- Lot
- Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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