Z-2559-2014Class III

Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic...

Name: Z-2559-2014 Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic...
Creator: Nanosphere, Inc.
Published: 2014-03-18
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2014-03-18 / Terminated

FDA source

Nanosphere, Inc. began a recall of Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19... on 2014-03-18. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2559-2014
Classification: Class III
Status: Terminated
Initiated: 2014-03-18
Posted: 2014-08-28
Terminated: 2015-07-02
Recalling firm: Luminex Corporation
Product: 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 code: NTI Drug Metabolizing Enzyme Genotyping Systems
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.
FDA root cause: Under Investigation by firm
Action: Nanosphere sent an Field Notification Letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions for customers to: 1) discontinue use of the affected products, 2) discard the affected product, and 3) complete and return the attached for to obtain free-of-charge replacement kits. Customers with any questions about this recall should contact their Nanosphere technical support representative at 1 888 837-4436. .
Quantity in commerce: 78 kits
Distribution: Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2559-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2559-2014	Class III	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28

Product code NTI

K120466Class IIVerigene Cyp2c19 Nucleic Acid Tes (2C19)Nanosphere, Inc. / cleared 2012-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)