Leica Biosystems Imaging, Inc.
Leica Biosystems Imaging, Inc. appears in FDA public data with 2 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0046-2020, Class II) was initiated on Dec 10, 2018. Its most recent 510(k) clearance was granted on Aug 7, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0046-2020 | Class II | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. | Dec 10, 2018 |
| Z-1152-2014 | Class II | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue | Feb 7, 2014 |