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 G0061 - G0701 14048858009

Issue

Leica Biosystems became aware, through post market surveillance, of an issue regarding poorly processed and/or damaged biopsy tissue specimens on the Histocore Pegasus / Histocore Pegasus Plus, resulting from incorrect assignment of the carryover value set for created or edited protocols. If the setup of carryover is lower than the actual carryover, it may potentially cause tissue damage (mainly under-processed tissue).

Recall start date: November 9, 2023

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-74662