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Histocore pegasus

Official notice

28 Nov 2023

Last checked

28 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Histocore pegasus. 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 Published 2023-11-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74662

Official notice

2023-11-28

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74662

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Affected products

Product 1

Affected products - Histocore Pegasus, Lot or serial number - G0061 - G0701, Model or catalogue number - 14048858009

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Leica Biosystems Nussloch, Histocore Pegasus.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74662

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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