Enforcement Report - Week of August 8, 2012
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Event Detail
| Event ID | 61882 |
|---|---|
| Product Type | Biologics |
| Status | Ongoing |
| Recalling Firm | Immucor Inc |
| City | Norcross |
| State | GA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-10 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Capture-R Ready Indicator Red Cells | Lot/Serial Number 221812 | Class III | Capture-R Ready Indicator Cells, with a rate of reported events for equivocal and unexpected positive reactions significantly higher than other lots, were distributed. | 747 units | B-2203-12 |
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