LumiQuick Legionella Test Cards Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Legionella Test Cards shipped to US locations without approved FDA applications.
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 (unauthorized distribution) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Legionella Test Cards (Catalog number 71034, all lots) because they were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance.
The recall affects all lots of the product. Distribution was limited to the states of California, Florida, New Jersey, Texas, and New York.
Consumers and facilities should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Legionella Test Card; LumiQuick, Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
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: 71034
- 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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