LumiQuick Benzodiazepine Strips Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Benzodiazepine Strips because they were shipped to US 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 driven by regulatory non-compliance (unapproved distribution) rather than a specific product defect or reported injury, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Benzodiazepine Strips (Catalog number 74017, all lots). The recall is due to the products being 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 and healthcare providers should stop using the affected Benzodiazepine Strips and contact the manufacturer for further instructions.
The recalled product
- Product
- Benzodiazepine Strip; 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: 74017
- 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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