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Terminated

CELLTRACKS ANALYZER II (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS AUTOPREP System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

FDA Recall Z-1195-2014 · Posted 2014-03-13

Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeNQI
Date Initiated2014-01-08
Date Terminated2017-07-06
Product Quantity19 units

Reason for Recall

Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.

Firm Action

Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130794CELLTRACKS ANALYZER II SYSTEMVeridex, LLC · 2013-06-20K050145CELLTRACKA ANALYZER IIImmunicon Corp. · 2005-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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