Reported May 1, 2024 · Ongoing
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Leica Biosystems Nussloch GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEICA BIOSYSTEMS NUSSLOCH GMBH · Heidelberger Str. 17-19 · Nussloch, N/A · N/A
Is this the product you have?
- Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
- Lot codes and dates
- All devices with serial numberG0061-G0701
- Amount recalled
- 98 devices
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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