Alere Cholestech LDX Lipid Profile-GLU Test Cassettes Recalled for Labeling Error
Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes because an incorrect lot number was printed on the packaging.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a documentation/packaging labeling error with no reported adverse health consequences or injuries.
Plain-English summary
Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes, Model 10-991, Lot #320167. The recall was initiated because an incorrect lot number, 321067, was printed on the outer 10-pack kit box label. The product is intended for the quantitative determination of total cholesterol, HDL cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.
The affected products were distributed nationwide in the United States and internationally to Canada. The expiration date for the recalled lot is 8/31/14.
Consumers and healthcare providers should stop using the affected test cassettes and contact Alere San Diego, Inc. for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 3,621
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: 10-991. Lot #320167. Expiration date
- or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.
Distribution
Distributed nationwide across the United States.
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