Reported Dec 20, 2017 · Terminated
enGen Track System with TCAutomation Software Version 4.2
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- enGen Track System with TCAutomation Software Version 4.2
- Lot codes and dates
- Serial numbers
5GV6W2J3RHC23J7KSC15J953252CXL941J & JG7BFB5J Product Code 952019-EG952020-EG952055
- Serial numbers
- Amount recalled
- 16
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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