FDAFDA · Food and drugs·Recall number Z-0254-2018
enGen Track System with TCAutomation Software Version 4.2
Published December 20, 2017 · Recall initiated: April 26, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
- Lot
- Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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