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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

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