Reported Dec 4, 2013 · Terminated
Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere…
Alere San Diego, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
- Product Brand Name(s)Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991
- Product Generic NameAlere Cholestech LDX¿ Lipid Profile"GLU Test Cassette
- Description of the productLipid. Glucose panel Test cassettes
- Product packaging10 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
- Lot codes and dates
- Model Number10-991. Lot #320167. Expiration date
- or Expected shelf life8/31/14
- Expected shelf lifeup to 12 months
- Amount recalled
- 3,621 kits
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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