Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit Recalled by Nanosphere, Inc. Due to Nanosphere has recieved reports related to an unacceptable...

Date: March 18, 2014
Company: Nanosphere, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nanosphere, Inc. directly.

Affected Products

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.

Quantity: 78 kits

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 7 states: AL, CA, MD, NJ, ND, OK, TX

Affected (7 states)Not affected

About Nanosphere, Inc.

Nanosphere, Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report