FDA recall Z-1530-2018

Product

CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

Reason for recall

Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

Distribution

Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy

Key facts

Status

Terminated

Initiation date

2018-04-04

Report date

2018-05-02

Termination date

2019-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntingdon Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1530-2018