Recall Z-0379-2014 ยท CGA Glucose Oxidase, Glucose
Alere San Diego, Inc.
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 lipoprot
| Date | Nov 22, 2013 (initiated Oct 23, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 3,621 kits |
| Distribution | Worldwide Distribution: USA (nationwide) and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120615 | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen, May 15, 2013 |