FDA Device recall Z-0379-2014
Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991
- FDA Device
- Class III
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class III recall of Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991 by Alere San Diego, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0379-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-10-23 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0379-2014%22
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