Cellavision AB: Medical Device Recall in 2018 - (Recall #: Z-2184-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 4, 2017

Date Posted: June 20, 2018

Recall Number: Z-2184-2018

Event ID: 80137

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.

Status: Ongoing

Product Quantity: Instruments: 224 Software: 99 (US)

Code Information:

Versions 6.0.1 or 6.0.2

Distribution Pattern:

US Nationwide in the states of FL, IL, NY, and NC

Voluntary or Mandated:

Voluntary: Firm initiated