Health product recall

Histocore Pegasus

Last updated

Summary

Product
Histocore Pegasus
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Histocore Pegasus

More than 10 numbers, contact manufacturer.

14048858009

Issue

Leica Biosystems became aware, through post market surveillance, of an issue regarding poorly processed or damaged biopsy tissue specimens on the Histocore Pegasus / Histocore Pegasus Plus, resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks. This recall is to inform customers of this issue and actions to be taken.

Recall start date: April 3, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies
Leica Biosystems Nussloch Gmbh
Heidelberger Street 17-19, Nussloch, Germany, 69226
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75407

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