Checkcell®
Brand(s)
Last updated
Summary
Product
Checkcell®
Issue
Medical devices - Sterility
What to do
Temporary corrective actions include product containment activities and a product recall.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Checkcell® | 43257 | 0002225 |
| Checkcell® | 43257 | 0002224 |
Issue
Some vials of Checkcell lot 43257 exhibited clot formation, hemolysis, and unexpected darkening of the red blood cells. Investigation determined that the clotting and abnormal darkening were associated with fungal growth within the vials.
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
Recall date
Identification number
RA-81438
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