Agency classClass IIIOur severity:Low FDA (Devices)·Z-0746-2013·Announced 2013-02-06

Alere Cholestech LDX Multianalyte Control Recalled for HDL Errors

Alere San Diego, Inc. is recalling Alere Cholestech LDX Multianalyte Control kits because they may produce out-of-range HDL cholesterol results.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Plain-English summary

Alere San Diego, Inc. is recalling Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number 88769. The recall involves 11,166 kits with lot numbers C2510, C2510A, C2572, C2572A, C2593, and C2593A. These products were distributed nationwide in the United States, as well as in Puerto Rico and South Korea.

The recall is being conducted because the controls may produce out-of-range (increased) HDL cholesterol results. The Alere Cholestech LDX Multianalyte Control is used to monitor the performance of various test procedures on the Alere Cholestech LDX System, including total cholesterol, HDL, triglycerides, glucose, and liver enzymes.

The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the affected control kits and contact the manufacturer for further instructions.

The recalled product

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)…
Manufacturer: Alere San Diego, Inc.
Category: Medical Device — Laboratory Control
Hazard: mis-labeling
Affected units: 11,166

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lot#C2510
C2510A
C2572
C2572A
C2593
and C2593A.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Alere San Diego, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Alere San Diego, Inc.

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