Enforcement Report - Week of November 14, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0252-2013 |
| Classification | Class II |
| Code Info | K082248 D089976 Ref 58104 units |
| Product Distributed Qty | 232 units US; 5 units Canada |
| Reason For Recall | 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®. |
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 |
-
