Nanosphere, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2559-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: March 18, 2014

Date Posted: September 3, 2014

Recall Number: Z-2559-2014

Event ID: 68710

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.

Status: Terminated

Product Quantity: 78 kits

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated