Enforcement Report - Week of October 24, 2012
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Event Detail
| Event ID | 62516 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Sunquest Information Systems, Inc. |
| City | Tucson |
| State | AZ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-11-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. | Versions 6.4.0 and later | Class III | Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10. | 127 sites | Z-0073-2013 |
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