Enforcement Report - Week of November 14, 2012
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Event Detail
| Event ID | 63270 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Diagnostica Stago, Inc. |
| City | Parsippany |
| State | NJ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-15 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and Canada |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. | K082248 D089976 Ref 58104 units | Class II | Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite®. | 232 units US; 5 units Canada | Z-0252-2013 |
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