Z-2681-2014 Class II Terminated
FDA device recall Z-2681-2014 was initiated by Nanosphere, Inc. on October 10, 2013 and is designated Class II. Reason for recall: 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 pro… The recall status is terminated (terminated June 16, 2015). Affected quantity: 400 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2014
- Initiation Date
- October 10, 2013
- Termination Date
- June 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14