Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Capture-R Ready Indicator Red Cells |
|---|---|
| Recall Number | B-2203-12 |
| Classification | Class III |
| Code Info | Lot/Serial Number 221812 |
| Product Distributed Qty | 747 units |
| Reason For Recall | Capture-R Ready Indicator Cells, with a rate of reported events for equivocal and unexpected positive reactions significantly higher than other lots, were distributed. |
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 |
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