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Ortho-Clinical Diagnostics recalls enGen Track System with TCAutomation Software Version 4.2
Recalled December 20, 2017 · FDA recall Z-0254-2018 · Ortho-Clinical Diagnostics
Hazard
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 · FDA Class II
Units
16
Sold at
Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
Description
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
Product
enGen Track System with TCAutomation Software Version 4.2
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →