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Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

FDA Recall #Z-0046-2020 — Class II — December 10, 2018

Recall #Z-0046-2020 Date: December 10, 2018 Classification: Class II Status: Terminated

Product Description

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

Reason for Recall

The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

Recalling Firm

Leica Biosystems Imaging, Inc. — Vista, CA

Classification

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

Product Type

Devices

Product Quantity

3 devices

Distribution

There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.

Code Information

Serial numbers 5899, 5902, and 5986.

Status

Terminated

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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