LumiQuick PCP Test Cards Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling PCP Test Cards because they were shipped to US locations without required FDA clearance.
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 does not report any illnesses, injuries, or hospitalizations, and the hazard is related to regulatory compliance rather than a direct physical defect causing harm.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling PCP Test Cards (Catalog number 74034, all lots) because the products were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance. The recall affects all units of this product.
The 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 who have these products should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- PCP Test Card; 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: 74034
- 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.
See all 80 products in this recall →Related recalls
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