Alere LDX Optical Check Cassettes Recalled for Incorrect Expiration Date
Alere San Diego, Inc. is recalling LDX Optical Check Cassettes because the expiration date on the magnetic strip does not match the labeled date.
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, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date, fitting the criteria for a Low severity score.
Plain-English summary
Alere San Diego, Inc. is recalling LDX Optical Check Cassettes (OCC), Model Numbers 10-228 and 14-535, Lot Number 332994. The recall involves 12,951 units distributed nationwide in the United States and in Japan, England, and Canada. The cassettes are used to check the optics system of the Alere Cholestech LDX Analyzer.
The recall was initiated because the expiration date printed on the magnetic strip of the cassette does not match the expiration date labeled on the packaging. This discrepancy is a labeling error.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 12,951
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 (1)
- Model Number: 10-228 and 14-535 Lot Number: 332994
Distribution
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