LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling CK-MB Test Cards 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 explicitly states no illnesses or injuries were reported, and the hazard is regulatory (unapproved distribution) rather than a direct physical defect causing harm.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (serum), catalog number 75007, all lots. The recall involves products shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance.
The recall is being conducted because the products were distributed in states including California, Florida, New Jersey, Texas, and New York without the necessary regulatory approvals. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these test cards.
Consumers and healthcare facilities should stop using the affected test cards and contact the manufacturer for further instructions.
The recalled product
- Product
- CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
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: 75007
- 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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