Recall Z-2559-2014— Nanosphere, Inc.

Name: FDA recall Z-2559-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-18

Class III · Terminated

Class III FDA medical device recall by Nanosphere, Inc., initiated 2014-03-18, terminated 2015-07-02. It names one FDA 510(k) clearance: K120466. 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.. Reason: 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..

Recalling firm: Nanosphere, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-03-18
Terminated: 2015-07-02
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)Nanosphere, Inc.·cleared 2012-11-06

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 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.

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