FDAFDA · Food and drugs·Recall number Z-0590-2024
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Published May 1, 2024 · Recall initiated: November 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Distributor
- US, Nationwide
- Lot
- All devices with serial number: G0061-G0701
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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