Home / Recalls / Nanosphere, Inc. / Z-2236-2014

Z-2236-2014 Class II Terminated

Recalled by Nanosphere, Inc. — Northbrook, IL

Recall Details

Product Type
Devices
Report Date
August 20, 2014
Initiation Date
July 9, 2014
Termination Date
September 1, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1045 extraction trays (840 affected by recall)

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.

Distribution Pattern

Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT

Code Information

VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14

Other recalls by Nanosphere, Inc.

  • Z-2170-2014 Class II — Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using (April 17, 2014)
  • Z-2559-2014 Class III — Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of (March 18, 2014)
  • Z-2168-2014 Class III — Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Te (October 16, 2013)
  • Z-2683-2014 Class II — The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed usi (October 10, 2013)
  • Z-2682-2014 Class II — The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, mul (October 10, 2013)
  • Z-2684-2014 Class II — The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene Syst (October 10, 2013)
  • Z-2681-2014 Class II — The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed us (October 10, 2013)
  • Z-2685-2014 Class II — The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitat (October 10, 2013)
  • Z-2736-2014 Class II — Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartri (June 17, 2013)
  • Z-2735-2014 Class II — Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartri (June 17, 2013)