LumiQuick Rotavirus Test Card Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling all lots of its Rotavirus Test Card because they were shipped to US locations without approved 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 corresponds to a moderate severity score when no specific physical injury or illness is reported in the source text.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Rotavirus Test Card (Catalog number 71029). The recall is being conducted 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 providers who have these test cards should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Rotavirus Test Card 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: 71029
- 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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