LumiQuick Strep A Test Card Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Strep A Test Cards because they were shipped to US 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 corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Strep A Test Cards (Catalog number 71048, all lots) because the products 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 healthcare providers should stop using the affected test cards and contact the manufacturer for further instructions.
The recalled product
- Product
- Strep A 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: 71048
- 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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