Enforcement Report - Week of February 6, 2013
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Product Detail
| Product Description | Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals. |
|---|---|
| Recall Number | Z-0747-2013 |
| Classification | Class III |
| Code Info | Lot#271097 |
| Product Distributed Qty | 320 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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