FDA-Device2018-06-20Class II
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 operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition
Cellavision AB
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.
Sold states
US Nationwide in the states of FL, IL, NY, and NC
Affected count
Instruments: 224 Software: 99 (US)
Manufactured in
Forskningsbyn Ideon, Scheelevagen 19a, Lund, N/A, Sweden
Products
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 operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2184-2018Don't want to check this manually?
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