CLASS II Device recall · Reported 26 Aug 2015 · FDA Enforcement Report

Cell Search Circulating Tumor Kit recalled by Veridex

Veridex is recalling Cell Search Circulating Tumor Kit, distributed nationwide in the US. The recall was initiated on 15 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12

Quantity recalled1560 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-2406-2015
FDA event ID: 71673
Recalling firm: Veridex, Raritan, NJ
Classification: Class II
Status: Terminated
Recall initiated: 15 May 2015
FDA classified: 18 Aug 2015
Reported: 26 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

15 May 2015	Recall initiated by company
18 Aug 2015	Classified by FDA	+95 days
26 Aug 2015	Published in enforcement report	+8 days

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

Reason for recall

Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Cell Search Circulating Tumor Kit recalled?

Yes. Veridex recalled Cell Search Circulating Tumor Kit on 15 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2406-2015.

Why was it recalled?

Which lots are affected?

Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12

Where was it sold?

Nationwide Distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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