LumiQuick Fecal Occult Blood Test Cards Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards because they were shipped to locations without approved FDA applications or 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, which typically corresponds to a moderate severity score. The hazard is a regulatory compliance issue rather than a direct physical safety defect, and no injuries or illnesses are reported.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards, catalog number 72001, all lots. 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. The recall covers all lots of the product.
Consumers who have these products should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
- 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: 72001
- 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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