Company: CellaVision AB.
Date of Enforcement Report 6/20/2018
Class II:
PRODUCT
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 Recall Number: Z-2184-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
CellaVision AB, Lund, Sweden on 12/4/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Instruments: 224 Software: 99 (US)
DISTRIBUTION
US Nationwide in the states of FL, IL, NY, NC.