Health product recall

Panocell-10 Reagent Red Blood Cells

Brand(s)
Last updated

Summary

Product
Panocell-10 Reagent Red Blood Cells
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

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

21934A

0003032

Panocell-10 Ficin Treated Reagent Red Blood Cells

19919-E

0002385

Issue

Immucor Inc. has indicated that this medical device recall is to communicate that some vials of indicated lot numbers 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 hemolysis and dark color. This issue is random across kits in these lots and is not present in all vials within the kit. 

Recall start date: June 27, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Immucor Inc.
3130 Gateway Drive, Norcross, Georgia, United States, 30071
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75807

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