Recall Z-0590-2024— LEICA BIOSYSTEMS NUSSLOCH GMBH
Class II · Ongoing
Class II FDA medical device recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, initiated 2023-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-20
- Firm location
- Nussloch, N/A, Germany
Product description
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.