Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
This recall is currently active, issued December 20, 2023. It was issued by Leica Biosystems Nussloch Gmbh Heidelberger Str. 17-19 Nussloch Germany.
- Recall Initiated
- November 20, 2023
- Posted
- December 20, 2023
- Recall Number
- Z-0590-2024
- Quantity
- 98 devices
- Official Source
- View on FDA website ↗
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.
Distribution
US, Nationwide
Lot / Code Info
All devices with serial number: G0061-G0701
Root Cause
Other
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.