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Alere San Diego, Inc. recalls Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Contro
Recalled February 6, 2013 · FDA recall Z-0746-2013 · Alere San Diego
Hazard
Out of range (increased) HDL Cholesterol results. · FDA Class III
Units
11,166 kits
Sold at
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Description
Out of range (increased) HDL Cholesterol results.
Product
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.
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →