Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use. |
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| Recall Number | Z-0463-2013 |
| Classification | Class II |
| Code Info | Lot # 120827, exp 11/27/2012 |
| Product Distributed Qty | 63 kits |
| Reason For Recall | Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values with "0" standard reducing the slope of the standard curve requiring more frequent sample dilutions. |
Event Detail
| Event Id | 63615 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Sekisui Diagnostics Llc |
| City | Stamford |
| State | CT | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA. |
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