Recall Z-0046-2020— Leica Biosystems Imaging, Inc.

Name: FDA recall Z-0046-2020
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Class II · Terminated

Class II FDA medical device recall by Leica Biosystems Imaging, Inc., initiated 2018-12-10, terminated 2021-04-28. It names one FDA 510(k) clearance: K141109. Product: Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.. Reason: 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.
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Terminated: 2021-04-28
Firm location: Vista, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEMLeica Biosystems Imaging, Inc.·cleared 2014-07-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.