Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. |
|---|---|
| Recall Number | Z-0073-2013 |
| Classification | Class III |
| Code Info | Versions 6.4.0 and later |
| Product Distributed Qty | 127 sites |
| Reason For Recall | 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. |
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 |
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