Veridex CellTracks Analyzer II Recalled for Patient Data Association Error
Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (incorrect patient data association) has been reported, but no injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Veridex, LLC is recalling the CellTracks Analyzer II software, versions 2.5.1 and below, due to a report that a patient's demographics were 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 for in vitro diagnostic use.
The issue involves the software's user interface, specifically the edit patient sample information screen introduced in software version 2.5.1. This screen includes a drop-down patient ID box on the right side that auto-populates previous sample data, a feature not explicitly mentioned in the release notes. The incorrect association of patient data poses a risk of misidentifying samples.
Approximately 70 units were distributed in the United States and 76 units were distributed internationally in Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy, and Spain. Users should follow the instructions provided in the notification to prevent further occurrences of this data association error on their systems.
The recalled product
- Product
- CELLTRACKS ANALYZER II (Software Version 2.5.1 & 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…
- Manufacturer
- Veridex, LLC
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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