LumiQuick Cardiac Panel Test Card Recalled for Regulatory Violations
LumiQuick Diagnostics is recalling Cardiac Panel Test Cards because they were shipped to locations without approved regulatory 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, and the source text indicates a regulatory compliance issue (shipping to unapproved locations) rather than a direct safety hazard with reported injuries, fitting the Moderate criteria for voluntary precautionary or compliance-driven recalls.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling the Cardiac Panel Test Card (Whole Blood), catalog number 75004, all lots. 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 affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. The recall covers all lots of the product.
Consumers and healthcare facilities should stop using the affected test cards and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- Cardiac Panel 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: 75004
- 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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