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
FDA Recall Z-1102-2007 · Posted 2007-07-24
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Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeNQI
Date Initiated2007-04-17
Date Terminated2007-12-06
Product QuantityLot 0036: 468 kits; Lot 0036A: 197 kits
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The 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.
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.
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