FDADecember 4, 2017device
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The oper...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
What to do
FDA enforcement status: Ongoing
Brands named
cellavision abcellavision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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