LumiQuick Syphilis Test Strips Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling all lots of Syphilis Test Strips (Serum) because they were shipped to locations without approved 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, which typically corresponds to a moderate severity score. The hazard involves regulatory non-compliance regarding distribution rather than a direct physical defect or reported injury.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Syphilis Test Strip (Serum), catalog number 71015. The recall covers all units of this product.
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. The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York.
Consumers and healthcare providers who have purchased or received these test strips should stop using them and contact LumiQuick Diagnostics for further instructions.
The recalled product
- Product
- Syphilis Test Strip (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: 71015
- 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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