FDA recall Z-0254-2018

Product

enGen Track System with TCAutomation Software Version 4.2

Reason for recall

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

Distribution

Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain

Key facts

Status

Terminated

Initiation date

2017-04-26

Report date

2017-12-20

Termination date

2021-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0254-2018