LumiQuick Adenovirus Antigen Test Card Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card because they were shipped to locations without approved FDA applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a regulatory violation regarding distribution to unapproved locations, which fits the criteria for a moderate severity recall without reported injuries.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card (Catalog number 71032). The recall was initiated because the products were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. This recall is classified as Class II by the FDA.
Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
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)
- Catalog number: 71032
- All lots
Distribution
Part of a larger recall action
This product is one of 80 recalled by LumiQuick Diagnostics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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