Reported Jun 12, 2024 · Ongoing
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
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 Tissue Processor, REF 14048858005.
- Lot codes and dates
- All devices with serial numbers
G0061 - G0154G0156 - G0530G0532 - G0779G0781G0782UDI-DI 04049188216397
- All devices with serial numbers
- Amount recalled
- 141 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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