Veridex, LLC Recall: CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product U
Veridex, LLC Recall: CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product U is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Veridex, LLC; Product: CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpo
| Recalling firm | Veridex, LLC |
|---|---|
| Product | CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the doc |
| Reason for recall | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain. |
| Recall initiated | 20121228 |
| Recall number | Z-1949-2013 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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