LumiQuick PSA Test Card Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling PSA Test Cards shipped to US locations without approved PMA, IDE, or 510(k) clearance.
What this means for you
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 specific health hazards, indicating a regulatory compliance issue rather than a direct safety threat.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling the PSA Test Card (Serum), catalog number 72003, all lots. The recall involves all units of this product.
The recall is being conducted because the products were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance. The product was distributed in the states of California, Florida, New Jersey, Texas, and New York.
Consumers and healthcare facilities should stop using the recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- 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: 72003
- 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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