PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: February 6, 2013 Initiated: October 22, 2012 #Z-0747-2013

Product Description

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.

Reason for Recall

Out of range (increased) HDL Cholesterol results.

Details

Recalling Firm
Alere San Diego, Inc.
Units Affected
614 kits
Distribution
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Alere San Diego, Inc.. Units affected: 614 kits.
Why was this product recalled? ▼
Out of range (increased) HDL Cholesterol results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2013. Severity: Low. Recall number: Z-0747-2013.

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