Leica recalls HistoCore Pegasus tissue processors with serial numbers G0061-G0154, G0156-G0530, G0532-G0779, G0781, G0782. Poor reagent levels cause damaged biopsy tissue.
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.
Leica is recalling specific HistoCore Pegasus tissue processors that may cause damaged biopsy tissue due to reagent levels exceeding safety marks. This affects lab users who process tissue samples.
The device may cause biopsy tissue damage if reagent levels exceed the maximum fill marks on the reagent bottles or paraffin tanks. This happens when the reagent is not properly measured or maintained.
Lab technicians and pathologists using the Leica HistoCore Pegasus tissue processor with the listed serial numbers are most at risk. The recall targets specific models sold in the U.S. market.
Check your HistoCore Pegasus tissue processor's serial number. The affected units have serial numbers from G0061 to G0154, G0156 to G0530, G0532 to G0779, G0781, or G0782.
Verify your device's serial number against the list: G0061-G0154, G0156-G0530, G0532-G0779, G0781, G0782.
Poorly processed or damaged biopsy tissue specimens may result if reagent levels exceed the maximum fill marks on reagent bottles or paraffin tanks.
Check your serial number: G0061 to G0154, G0156 to G0530, G0532 to G0779, G0781, or G0782.
The recall does not provide a fix; users should check if their device is affected and contact Leica if needed.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-1947-2024 — Leica Leica Hello, I own a Leica that is covered by recall Z-1947-2024 from Leica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.