Medical Device Recalls

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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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 det...	2	09/23/2014	FEI # 3006028115 Nanosphere, Inc.
Z-2682-2014 - The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of ...	2	09/23/2014	FEI # 3006028115 Nanosphere, Inc.
Z-2685-2014 - The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence marke...	2	09/23/2014	FEI # 3006028115 Nanosphere, Inc.
Z-2684-2014 - The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory viru...	2	09/23/2014	FEI # 3006028115 Nanosphere, Inc.
Z-2683-2014 - The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous dete...	2	09/23/2014	FEI # 3006028115 Nanosphere, Inc.