The Recall Desk
ModerateFDA (Devices)·Z-2184-2018·Announced 2018-06-20

CellaVision DM Software Recall for LIS Data Transmission Malfunction

Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 due to a malfunction where cell comments are not sent to the Laboratory Information System.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported. The hazard is a data transmission error rather than a direct physical injury risk.

Plain-English summary

Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 installed on CellaVision DM96, DM1200, DM9600, and DI-60 instruments. The recall involves 224 instruments and 99 software units in the United States, distributed nationwide in Florida, Illinois, New York, and North Carolina.

The recall is due to a software malfunction where White Blood Cell (WBC), Red Blood Cell (RBC), and Platelet (PLT) comments added after a slide is signed are not sent to the Laboratory Information System (LIS). This issue only occurs where customers process multiple slides per blood sample.

The devices are automated cell-locating instruments intended for use by skilled operators trained in blood cell recognition. No specific consumer action is detailed in the source text beyond the identification of the affected software versions and instruments.

The recalled product

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 b
Manufacturer
Cellavision AB
Category
Medical Device — Laboratory Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Versions 6.0.1 or 6.0.2

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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