Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.
- Company
- Alere San Diego, Inc.
- Recall Initiated
- October 23, 2013
- Posted
- November 22, 2013
- Terminated
- September 25, 2014
- Recall Number
- Z-0379-2014
- Quantity
- 3,621 kits
- Firm Location
- San Diego, CA
Reason for Recall
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.
Distribution
Worldwide Distribution: USA (nationwide) and Internationally to Canada.
Lot / Code Info
Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.
Root Cause
Labeling Change Control
Action Taken
Alere initiated this recall by sending out notification letters to customers via fax, email, or direct mail. The letter titled "URGENT MEDICAL DEVICE NOTICE", dated October 23, 2013 is accompanied by a response form/Verification form. The notification informed customers of the reason for recall, product description with codes, required actions by the customers, and contact information.