Company:Ortho-Clinical Diagnostics
Date of Enforcement Report 12/20/2017
Class lI:

PRODUCT

enGen Track System with TCAutomation Software Version 4.2
Recall Number Z-0254-2018

REASON
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

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 4/26/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
16

DISTRIBUTION
GA, IL, MO, NC & NY and Internationally

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