FDAFDA · Food and drugs·Recall number Z-0746-2013
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.
Published February 6, 2013 · Recall initiated: October 22, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of range (increased) HDL Cholesterol results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alere San Diego, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
- Lot
- Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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