CELLSEARCH Circulating Tumor Cell Kit (2015-05-19)

Starting date:

May 19, 2015

Posting date:

June 15, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53801

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  Reason
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  Affected products

Recalled Products

1. CELLSEARCH Circulating Tumor Cell Kit

Reason

Janssen Diagnostics LLC has received reports from customers about the intermittent occurrence of small bead-like structures or "artifacts" appearing in the image gallery for both control cells and patient samples of some cell search circulating tumor cell kits. The appearance of individual artifacts is not unusual. However, review of the data has demonstrated an increase of artifacts appearing in the image gallery as unassigned events. Artifacts are distinguishable from circulating tumor cells (CTCS) as they do not meet the criteria of a CTC. Therefore, they are not likely to be counted as CTCS when reviewing in the image gallery. However, when testing patient samples, there is a low probability that this type of artifact could potentially obscure the presence of CTCS.

Affected products