Enforcement Report - Week of August 15, 2012
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Product Detail
| Product Description | SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. |
|---|---|
| Recall Number | Z-2143-2012 |
| Classification | Class II |
| Code Info | SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. |
| Product Distributed Qty | 88 |
| Reason For Recall | On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu. |
Event Detail
| Event Id | 62023 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | SCC Soft Computer |
| City | Clearwater |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-10-17 |
| Initial Firm Notification of Consignee or Public | Other |
| Distribution Pattern | US Nationwide Distribution |
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