LumiQuick Barbiturate Test Cards Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Barbiturate Test Cards because they were shipped to locations without required FDA clearance.
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 indicates a temporary or medically reversible adverse health consequence. The specific hazard is regulatory non-compliance regarding distribution to unauthorized locations, which fits the criteria for a moderate severity recall involving labeling or regulatory issues without reported injuries.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Barbiturate Test Card (Catalog number 74016). 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 and healthcare facilities should stop using the affected test cards and contact the recalling firm for instructions on how to return the product.
The recalled product
- Product
- Barbiturate 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: 74016
- 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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