FDA Recall
Open, Classified
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Recall: Z-0590-2024
·
Initiated November 20, 2023
Recall
- Recall Number
- Z-0590-2024
- Event Number
- 93467
- Firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany
- FEI Number
- 3002179321
- Product Code
- IEO
- Status
- Open, Classified
- Root Cause
- Other
- Initiated
- November 20, 2023
- Posted
- December 20, 2023
Description
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Reason
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
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.
Distribution
US, Nationwide
Quantity
98 devices