Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. |
|---|---|
| Recall Number | Z-0251-2013 |
| Classification | Class II |
| Code Info | v3.0.0_07222004 and later |
| Product Distributed Qty | 9 units |
| Reason For Recall | The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately. |
Event Detail
| Event Id | 63380 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Sunquest Information Systems, Inc. |
| City | Tucson |
| State | AZ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2009-11-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
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