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CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision ...

FDA Recall #Z-2184-2018 — Class II — December 4, 2017

Recall #Z-2184-2018 Date: December 4, 2017 Classification: Class II Status: Ongoing

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

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.

Recalling Firm

Cellavision AB — Lund, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

Instruments: 224 Software: 99 (US)

Distribution

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

Code Information

Versions 6.0.1 or 6.0.2

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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