Ortho-Clinical Diagnostics recalls enGen Track System with TCAutomation Software Version 4.2
- Recall date
- April 26, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0254-2018
- FDA classification
- Class II
- Brand / firm
- Ortho-Clinical Diagnostics
- Sold / distributed
- Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
Why it was 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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
enGen Track System with TCAutomation Software Version 4.2
Get recall alerts
Free email alert whenever Ortho-Clinical Diagnostics has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Ortho-Clinical Diagnostics