Public recall detail

Panoscreen I And II , 2-4% Suspension

2024-07-10

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Recall Safety notice
Quick summary

Quick summary: Panoscreen I And II , 2-4% Suspension. Date: 2024-07-10.

Recommended action

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

Recall details

Quick summary: Panoscreen I And II , 2-4% Suspension. Date: 2024-07-10.

Official details

Affected product details

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

BrandImmucor Inc.
ProductPanoscreen I And II , 2-4% Suspension
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75802

Affected products

ProductPanoscreen I And II , 2-4% Suspension
Lot18915
Model0002380
Serial number18915
DescriptionPanoscreen I And II , 2-4% Suspension

Issue

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

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-75802
Background{}
CompaniesImmucor Inc. 3130 Gateway Drive, Norcross, Georgia, United States, 30071
AudiencesHealthcare
Source updated2024-07-10

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

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