Public recall detail

Panocell-10 (2-4% Suspension) Reagent Red Blood Cells

2024-07-04

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Recall Safety notice
Quick summary

Quick summary: Panocell-10 (2-4% Suspension) Reagent Red Blood Cells. Date: 2024-07-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Panocell-10 (2-4% Suspension) Reagent Red Blood Cells. Date: 2024-07-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandImmucor Inc.
ProductPanocell-10 (2-4% Suspension) Reagent Red Blood Cells
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75777

Affected products

ProductPanocell-10 (2-4% Suspension) Reagent Red Blood Cells
Lot17905
Model0003032
Serial number17905
DescriptionPanocell-10 (2-4% Suspension) Reagent Red Blood Cells

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesImmucor Inc. 3130 Gateway Drive, Norcross, Georgia, United States, 30071
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75777
Background{}
CompaniesImmucor Inc. 3130 Gateway Drive, Norcross, Georgia, United States, 30071
AudiencesHealthcare
Source updated2024-07-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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