Enforcement Report - Week of December 12, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Lot # 120827, exp 11/27/2012 | Class II | 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. | 63 kits | Z-0463-2013 |
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