FDAClass IIIFebruary 6, 2013

Alere Cholestech LDX Multianalyte Control recall

Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as…

Why was Alere Cholestech LDX Multianalyte Control recalled?

Out of range (increased) HDL Cholesterol results.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as…
Recalling firm
Alere San Diego, Inc.
Quantity
11,166 kits
Distribution
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Recall date
February 6, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls