Histocore Pegasus
Brand(s)
Last updated
Summary
Product
Histocore Pegasus
Issue
Medical devices - Performance
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
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