LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Syphilis Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) 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 identifies the issue as a regulatory distribution violation (shipping to unapproved locations) rather than a direct physical defect or reported injury. This aligns with the rubric for moderate severity involving compliance or labeling issues without reported harm.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Syphilis Test Card (Serum), catalog number 71057. 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 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 providers who have purchased or received these test cards should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Syphilis 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: 71057
- 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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