FDA-Device2013-02-06Class III
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. Howe
Alere San Diego, Inc.
Hazard
Out of range (increased) HDL Cholesterol results.
Sold states
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Affected count
614 kits
Manufactured in
9975 Summers Ridge Rd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0747-2013Don't want to check this manually?
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