Enforcement Report - Week of February 6, 2013
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Product Detail
| Product Description | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System. |
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| Recall Number | Z-0746-2013 |
| Classification | Class III |
| Code Info | Lot#C2510 and C2510A |
| Product Distributed Qty | 2,471 kits |
| Reason For Recall | Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results. |
Event Detail
| Event Id | 63918 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Alere San Diego, Inc. |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea. |
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