Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
FDA device recall Z-0046-2020 · posted 2019-10-04 · Terminated
Recall details
- Recalling firm
- Leica Biosystems Imaging, Inc.
- 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.
- Action taken
- The consignees were notified beginning on 12/10/2018 via letter delivered by email.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- NOT
- Quantity affected
- 3 devices
- Distribution
- There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
- Date initiated
- 2018-12-10
- Date posted
- 2019-10-04
- Date terminated
- 2021-04-28
- Location
- Vista, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APERIO EPATHOLOGY EIHC IVD SYSTEM (K141109) | Leica Biosystems Imaging, Inc. | 2014-07-29 |