Alere San Diego, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0746-2013)

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 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.

Product Classification:

Class III

Date Initiated: October 22, 2012

Date Posted: February 6, 2013

Recall Number: Z-0746-2013

Event ID: 63918

Reason for Recall:

Out of range (increased) HDL Cholesterol results.

Status: Terminated

Product Quantity: 11,166 kits

Code Information:

Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated