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 - G0154
    • G0156 - G0530
    • G0532 - G0779
    • G0781
    • G0782
    • UDI-DI 04049188216397
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.