Recall Z-0590-2024 ยท IEO Processor, Tissue, Automated
LEICA BIOSYSTEMS NUSSLOCH GMBH
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
| Date | Dec 20, 2023 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 98 devices |
| Distribution | US, Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.