Recall Z-2236-2014— Nanosphere, Inc.

Name: FDA recall Z-2236-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-09

Class II · Terminated

Class II FDA medical device recall by Nanosphere, Inc., initiated 2014-07-09, terminated 2015-09-01. It names one FDA 510(k) clearance: K132843. Product: Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.. Reason: Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction..

Recalling firm: Nanosphere, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Terminated: 2015-09-01
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

Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.

Reason for recall

Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.

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