Z-0046-2020Class II

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

Name: Z-0046-2020 Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE
Creator: Leica Biosystems Imaging, Inc.
Published: 2018-12-10
License: https://open.fda.gov/license/

Leica Biosystems Imaging, Inc. / initiated 2018-12-10 / Terminated / root cause: design

FDA source

Leica Biosystems Imaging, Inc. began a recall of Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE on 2018-12-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0046-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Posted: 2019-10-04
Terminated: 2021-04-28
Recalling firm: Leica Biosystems Imaging, Inc.
Product: Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Product code: NOT Microscope, Automated, Image Analysis, Operator Intervention
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: The consignees were notified beginning on 12/10/2018 via letter delivered by email.
Quantity in commerce: 3 devices
Distribution: There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
Product codes and lots: Serial numbers 5899, 5902, and 5986.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0046-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0046-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04

Product code NOT

K141109Class IIAperio Epathology Eihc IVD SystemLeica Biosystems Imaging, Inc. / cleared 2014-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)