Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
enGen Track System with TCAutomation Software Version 4.2 Recalled by Ortho-Clinical Diagnostics Due to A software anomaly with TCA Software V4.2 may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics directly.
Affected Products
enGen Track System with TCAutomation Software Version 4.2
Quantity: 16
Why Was This Recalled?
A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
Where Was This Sold?
This product was distributed to 5 states: GA, IL, MO, NY, NC
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report