LumiQuick Rickettsia Test Cards Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Rickettsia IgG/IgM Test Cards because they were shipped to locations without required FDA clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any illnesses or injuries, and the hazard is primarily regulatory (unauthorized distribution) rather than a direct physical defect causing harm.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Rickettsia IgG/IgM Test Cards (Catalog number 71017, 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 covers all units distributed in California, Florida, New Jersey, Texas, and New York.
The recall is due to regulatory non-compliance regarding the distribution of medical devices to facilities lacking the necessary FDA authorizations. No specific illnesses, injuries, or adverse health consequences are reported in the source text.
Consumers and healthcare facilities should stop using the affected test cards and contact LumiQuick Diagnostics Inc. for further instructions on return or disposal.
The recalled product
- Product
- Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
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: 71017
- 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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