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Panocell-10 (2-4% suspension) reagent red blood cells

Official notice

4 Jul 2024

Last checked

4 Jul 2024

Critical riskHealth Canada

An official Health Canada notice concerns Panocell-10 (2-4% suspension) reagent red blood cells. Some vials of Panocell-10 lot 17905, exhibit an unexpected dark color (hemolysis) and darkening of the red blood cells. It has been confirmed that there is fungal growth in the vials where the hemolysis and darkening of the red blood cells has been observed. This issue is random across kits within Panocell-10, lot 17905 and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall Start Date: June 6, 2024 Published 2024-07-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75777

Official notice

2024-07-04

The hazard

Some vials of Panocell-10 lot 17905, exhibit an unexpected dark color (hemolysis) and darkening of the red blood cells. It has been confirmed that there is fungal growth in the vials where the hemolysis and darkening of the red blood cells has been observed. This issue is random across kits within Panocell-10, lot 17905 and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall Start Date: June 6, 2024

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.

Lots

17905, exhibit, is

Recall Numbers

75777

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Affected products

Product 1

Affected products - Panocell-10 (2-4% Suspension) Reagent Red Blood Cells, Lot or serial number - 17905, Model or catalog number - 0003032

Risk / hazard

Some vials of Panocell-10 lot 17905, exhibit an unexpected dark color (hemolysis) and darkening of the red blood cells. It has been confirmed that there is fungal growth in the vials where the hemolysis and darkening of the red blood cells has been observed. This issue is random across kits within Panocell-10, lot 17905 and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall Start Date: June 6, 2024

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: Immucor, Panocell-10 Reagent Red Blood Cells.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

75777

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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