Alere San Diego, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0747-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: October 22, 2012

Date Posted: February 6, 2013

Recall Number: Z-0747-2013

Event ID: 63918

Reason for Recall:

Out of range (increased) HDL Cholesterol results.

Status: Terminated

Product Quantity: 614 kits

Code Information:

Lot#271097, 298148, and 301886

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated