Class 2 Device Recall CellaVision DM96, DM1200, DM9600 and DI60

• Date Initiated by Firm: December 04, 2017
• Create Date: June 13, 2018
• Recall Status: Open, Classified
• Recall Number: Z-2184-2018
• Recall Event ID: 80137
• 510(K)Number: K033840 K092868
• Product Classification: Device, automated cell-locating - Product Code JOY
• 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
• Code Information: Versions 6.0.1 or 6.0.2
• Recalling Firm/ Manufacturer: Cellavision AB; Forskningsbyn Ideon; Scheelevagen 19a; Lund Sweden
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision (service@cellavision.se)
• Quantity in Commerce: Instruments: 224 Software: 99 (US)
• Distribution: US Nationwide in the states of FL, IL, NY, and NC
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JOY