CLASS III Device recall · Reported 3 Sep 2014 · FDA Enforcement Report

Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) recalled by Nanosphere

Nanosphere is recalling Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test), distributed nationwide in the US. The recall was initiated on 18 Mar 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes(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

Quantity recalled78 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2559-2014
FDA event ID: 68710
Recalling firm: Nanosphere, Northbrook, IL
Classification: Class III
Status: Terminated
Recall initiated: 18 Mar 2014
FDA classified: 28 Aug 2014
Reported: 3 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Mar 2014	Recall initiated by company
28 Aug 2014	Classified by FDA	+163 days
3 Sep 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alabama California Maryland North Dakota New Jersey Oklahoma Texas

Questions about this recall

Is Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) recalled?

Yes. Nanosphere recalled Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) on 18 Mar 2014. The recall is Class III and its status is Terminated. Recall number Z-2559-2014.

Why was it recalled?

Which lots are affected?

(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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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