CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
FDA Recall Z-2175-2010 · Posted 2010-08-05
Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeGKH
Date Initiated2010-05-19
Date Terminated2014-05-08
Product Quantity101 Domestically, 87 Internationally
Reason for Recall
Complaints of patient sample carryover.
Firm Action
On 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339.
Root Cause
Process control
Distribution Pattern
Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.