Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
FDA device recall Z-0590-2024 · posted 2023-12-20 · Open, Classified
Recall details
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Reason for recall
- There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.
- Action taken
- Leica issued an URGENT Medical Device Recall notice to its consignees on 11/20/2023 via email. The notice explained the issue with the device and instructed the consignee to ensure the selection of the correct setting of the carryover value for al created or edited protocols and follow the instructions in the IFU.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- IEO
- Quantity affected
- 98 devices
- Distribution
- US, Nationwide
- Date initiated
- 2023-11-20
- Date posted
- 2023-12-20
- Location
- Nussloch, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.