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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67447

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 08, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Veridex, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1195-2014
Recall number
Z-1195-2014
Initiated
January 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Veridex, LLC
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

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

Code information

First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555 Serial numbers: CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024

Distribution pattern

Worldwide Distribution - USA Nationwide

Field note

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