Device 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.
Z-0379-2014
Product summary
- Event
- Event 66663
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,621 kits
- Official record key
device-enforcement:Z-0379-2014
Official wording
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.
Code information: Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.
Distribution pattern: Worldwide Distribution: USA (nationwide) and Internationally to Canada.
Derived failure modes
-
Labeling or packaging
label. The incorrect