FDAFDA · Food and drugs·Recall number Z-0747-2013
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.
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#271097, 298148, and 301886
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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