Alere Cholestech LDX Multianalyte Control — Class III medical device recall Z-0746-2013

Terminated recall by Alere San Diego, Inc., reported 2013-02-06, distributed nationwide. Out of range (increased) HDL Cholesterol results.

Recall number	`Z-0746-2013`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Alere San Diego, Inc., San Diego, CA, United States
Recall initiated	2012-10-22
Classified	2013-01-29
Reported by FDA	2013-02-06
Terminated	2013-09-26
Distributed	Nationwide (US)
Countries outside the US	KR
Quantity	11,166 kits
Lot numbers	`C2510`, `C2510A`, `C2572`, `C2572A`, `C2593`, `C2593A`
Model numbers	`88769`

Product

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.

Reason for recall

Out of range (increased) HDL Cholesterol results.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0746-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.