LumiQuick H. Pylori Antibody Test Card Recalled for Regulatory Non-Compliance
LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards because they were shipped to locations without required FDA regulatory clearances.
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, but the source text explicitly states no illnesses or injuries were reported and the hazard is regulatory (lack of clearance) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards (Whole Blood), catalog number 71024, all lots. The recall is due to the products being 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. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these test cards.
Consumers and healthcare providers should stop using the recalled test cards and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
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: 71024
- 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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