Recall Z-1947-2024— LEICA BIOSYSTEMS NUSSLOCH GMBH
Class II · Ongoing
Class II FDA medical device recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, initiated 2024-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.. Reason: Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks..
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-10
- Firm location
- Nussloch, N/A, Germany
Product description
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Reason for recall
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.