Z-2406-2015 Class II Terminated
FDA device recall Z-2406-2015 was initiated by Veridex, LLC on May 15, 2015 and is designated Class II. 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 ce… The recall status is terminated (terminated March 30, 2016). Affected quantity: 1560 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2015
- Initiation Date
- May 15, 2015
- Termination Date
- March 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1560 kits
Product Description
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12