Home / Recalls / Nanosphere, Inc. / Z-2559-2014

Z-2559-2014 Class III Terminated

Recalled by Nanosphere, Inc. — Northbrook, IL

FDA device recall Z-2559-2014 was initiated by Nanosphere, Inc. on March 18, 2014 and is designated Class III. Reason for recall: Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal tes… The recall status is terminated (terminated July 2, 2015). Affected quantity: 78 kits.

Recall Details

Product Type
Devices
Report Date
September 3, 2014
Initiation Date
March 18, 2014
Termination Date
July 2, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
78 kits

Product Description

Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.

Reason for Recall

Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.

Distribution Pattern

Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.

Code Information

(Catalog No. 20-005-019) Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1 Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1

Other recalls by Nanosphere, Inc.

  • Z-2236-2014 Class II — Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC- (July 9, 2014)
  • Z-2170-2014 Class II — Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using (April 17, 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-2684-2014 Class II — The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene Syst (October 10, 2013)
  • Z-2685-2014 Class II — The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitat (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-2682-2014 Class II — The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, mul (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)

FDA data resources