CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.
FDA Recall Z-0819-2010 · Posted 2010-02-23
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Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeNQI
Date Initiated2009-08-12
Date Terminated2012-07-18
Product Quantity1641 in US, 380 internationally.
Reason for Recall
Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.
Firm Action
Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).
Root Cause
Other
Distribution Pattern
Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.
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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