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U.S. Department of Health and Human Services

Class 3 Device Recall Veridex

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 Class 3 Device Recall Veridexsee related information
Date Initiated by FirmApril 17, 2007
Date PostedJuly 24, 2007
Recall Status1 Terminated 3 on December 06, 2007
Recall NumberZ-1102-2007
Recall Event ID 38206
510(K)NumberK050245 K052191 K062013 
Product Classification in vitro diagnostic - Product Code NQI
ProductCell 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
Code Information Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
FEI Number 3004582358
Recalling Firm/
Manufacturer		 Veridex, LLC
33 Technology Dr
Warren NJ 07059-5148
For Additional Information ContactDebra Rasmussen
908-791-2438
Manufacturer Reason
for Recall		An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
FDA Determined
Cause 2		Other
ActionAll 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.
Quantity in CommerceLot 0036: 468 kits; Lot 0036A: 197 kits
DistributionThe kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NQI
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