LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution
LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum) because they were 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 indicates a regulatory compliance issue (unapproved distribution) rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity voluntary/precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum), catalog number 75005, all lots. The recall involves products distributed in California, Florida, New Jersey, Texas, and New York.
The recall was initiated because the products were shipped to US locations that do not have approved applications for Premarket Approval (PMA), Investigational Device Exemption (IDE), or 510(k) clearance. This indicates a regulatory compliance issue regarding the distribution of the medical device.
Healthcare facilities and laboratories that received these test cards should stop using them and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Myoglobin 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: 75005
- 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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