Veridex, LLC Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA
Brand
Veridex, LLC
Lot Codes / Batch Numbers
Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
Products Sold
Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
Veridex, LLC is recalling Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Ver due to An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
Recommended Action
Per FDA guidance
All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026