Health product recall

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

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

A. CELLSEARCH Circulating Tumor Cell Kit

Lot or serial number
  • 0074B
  • 0094B
Model or catalog number
  • 7900001
Companies
Manufacturer

Janssen Diagnostics, LLC

700 US Hwy 202 South

Paritan

08869

New Jersey

UNITED STATES