Reported Aug 26, 2015 · Terminated

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

Veridex, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Veridex, LLC · 1001 US Route 202 · Raritan, NJ · 08869-0606

Is this the product you have?

  • Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Lot codes and dates
    • Part Number 7900001
    • Kit Lot Number 0074B Exp Date 2015-10-08
    • Kit Lot Number 0094B Exp Date 2015-12-12
Amount recalled
1560 kits

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 30, 2016 · Data as of Sep 19, 4:46 PM UTC

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