Veridex CellTracks AutoPrep System Recalled for Patient Data Mismatch
Veridex is recalling CellTracks AutoPrep System software due to a reported error where patient demographics were incorrectly associated with another patient's ID.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a specific error (patient data mismatch) has been reported, but no injuries or illnesses are explicitly stated in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Veridex, LLC is recalling the CellTracks AutoPrep System, specifically software version 2.4.1 and below. The recall was initiated after the company received a report that a patient's demographic information was incorrectly associated with another patient's identification (PID) number.
The CellTracks AutoPrep System is a general-purpose laboratory instrument used with immunomagnetic reagents to capture and enrich target cells in whole blood. It is intended for in vitro diagnostic use and is often used in conjunction with cell analyzers such as the CellTracks Analyzer II. The software issue involves the ability to modify batch information and enter expanded sample and patient details.
The recall affects 82 units in the United States and 78 units outside the US. Distribution was worldwide, including the USA, Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy, and Spain. Users should follow the instructions provided in the notification to help prevent this occurrence on their CellTracks AutoPrep System and CellTracks Analyzer II.
The recalled product
- 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 who
- Manufacturer
- Veridex, LLC
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Veridex, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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