Panocell-10 Reagent Red Blood Cells
Brand(s)
Last updated
Summary
Product
Panocell-10 Reagent Red Blood Cells
Issue
Medical devices - Performance
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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