Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Reported: May 1, 2024 Initiated: November 20, 2023 #Z-0590-2024
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.
Details
- Recalling Firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Units Affected
- 98 devices
- Distribution
- US, Nationwide
- Location
- Nussloch, N/A
Frequently Asked Questions
What product was recalled? ▼
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED). Recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH. Units affected: 98 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-0590-2024.
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