CELLTRACKS ANALYZER II¿ — Class II medical device recall Z-1195-2014
Terminated recall by Veridex, LLC, reported 2014-03-19, distributed nationwide. Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.
| Recall number | Z-1195-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Veridex, LLC, Raritan, NJ, United States |
| Recall initiated | 2014-01-08 |
| Classified | 2014-03-12 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2017-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 19 units |
| Serial numbers | CT1104002, CT1106005, CT1108006, CT1111009, CT1201001, CT1203004, CT1205011, CT1205012, CT1206013, CT1210022, CT1210024 |
Product
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.
Reason for recall
Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1195-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.