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Terminated

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

FDA Recall Z-0046-2020 · Posted 2019-10-04

Recalling FirmLeica Biosystems Imaging, Inc.
Recall StatusTerminated
Product CodeNOT
Date Initiated2018-12-10
Date Terminated2021-04-28
Product Quantity3 devices

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.

Firm Action

The consignees were notified beginning on 12/10/2018 via letter delivered by email.

Root Cause

Component design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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