LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution
LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood) because they were shipped to US locations without required FDA 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, fitting the criteria for a moderate severity voluntary or compliance-driven recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood), catalog number 75008, all lots. The recall involves all units of this product.
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. This indicates a regulatory compliance issue regarding the distribution of the medical device.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. Consumers and healthcare facilities should stop using these test cards and contact the manufacturer for further instructions.
The recalled product
- Product
- CK-MB 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: 75008
- 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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