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Panoscreen i and ii , 2-4% suspension

Official notice

10 Jul 2024

Last checked

10 Jul 2024

Critical riskHealth Canada

An official Health Canada notice concerns Panoscreen i and ii , 2-4% suspension. Immucor Inc. Has indicated that this medical device recall is to communicate that some vials of this lot (18915) 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 demonstrating dark color. This issue is random across kits in this lot and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall start date: June 12, 2024 Published 2024-07-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75802

Official notice

2024-07-10

The hazard

Immucor Inc. Has indicated that this medical device recall is to communicate that some vials of this lot (18915) 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 demonstrating dark color. This issue is random across kits in this lot and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall start date: June 12, 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.

Recall Numbers

75802

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Affected products

Product 1

Affected products - Panoscreen I And II , 2-4% Suspension, Lot or serial number - 18915, Model or catalogue number - 0002380

Risk / hazard

Immucor Inc. Has indicated that this medical device recall is to communicate that some vials of this lot (18915) 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 demonstrating dark color. This issue is random across kits in this lot and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall start date: June 12, 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, Panoscreen I And Ii 2-4% Suspension.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

75802

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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