Recall Z-2681-2014— Nanosphere, Inc.

Name: FDA recall Z-2681-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-10

Class II · Terminated

Class II FDA medical device recall by Nanosphere, Inc., initiated 2013-10-10, terminated 2015-06-16. It names one FDA 510(k) clearance: K132843. Product: 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: 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..

Recalling firm: Nanosphere, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Terminated: 2015-06-16
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)Nanosphere, Inc.·cleared 2014-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.