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Alere San Diego, Inc. recalls Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Ver
Recalled February 6, 2013 · FDA recall Z-0747-2013 · Alere San Diego
Hazard
Out of range (increased) HDL Cholesterol results. · FDA Class III
Units
614 kits
Sold at
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Description
Out of range (increased) HDL Cholesterol results.
Product
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.
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →