LumiQuick Tuberculosis Antibody Test Card Serum Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Tuberculosis Antibody Test Card Serum because it was shipped to locations without required FDA clearances.
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 and involves a regulatory compliance issue (shipping without clearance) rather than a direct physical hazard or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Tuberculosis Antibody Test Card Serum (Catalog number 71062). 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.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. This recall is classified as Class II by the FDA.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Hazard
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: 71062
- 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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