FDAClass IIIDecember 4, 2013

Product Brand Name(s): Alere Cholestech LDX¿ Lipid recall

Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid…

Why was Product Brand Name(s): Alere Cholestech LDX¿ Lipid recalled?

Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.

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?

Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.

Product
Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid…
Recalling firm
Alere San Diego, Inc.
Quantity
3,621 kits
Distribution
Worldwide Distribution: USA (nationwide) and Internationally to Canada.
Recall date
December 4, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls