Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry |
|---|---|
| Recall Number | Z-2270-2012 |
| Classification | Class II |
| Code Info | Versions 6.4 and later |
| Product Distributed Qty | 127 sites |
| Reason For Recall | The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information. |
Event Detail
| Event Id | 62708 |
|---|---|
| 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 | 2011-12-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- USA (nationwide) and the country of Canada. |
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