Enforcement Report - Week of August 8, 2012
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Event Detail
| Event ID | 62501 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Sunquest Information Systems, Inc. |
| City | Tucson |
| State | AZ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2009-12-14 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Sunquest Laboratory Blood Bank and Blood Donor | Sunquest Blood Bank and Blood Donor versions: Sunquest Blood Bank and Blood Donor versions 6.0.1 Distributed with Sunquest Laboratory 6.1; 6.0.1 Distributed with Sunquest Laboratory 6.2; 6.0.2 Distributed with Sunquest Laboratory 6.3; 6.4 Distributed with Sunquest Laboratory 6.4 | Class III | Software, with a glitch or defect, was distributed. | 4 products | B-2202-12 |
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