Medical Device Assay Kits Recalled for Potential Instrument Leakage
Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.
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: This is an FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is a potential leak with no documented incidents, making this a voluntary precautionary recall consistent with Moderate severity.
Plain-English summary
Luminex Corporation is recalling 296 kits of the ARIES HSV 1&2 Assay (Part Number/REF 50-10017, Lot AB1703A). The ARIES HSV 1&2 Assay is a molecular diagnostic test kit used to detect Herpes Simplex Virus types 1 and 2.
The recalled kits are subject to a defect in which the impacted lot may leak inside the ARIES instrument during use.
The affected kits were distributed nationwide in the United States and in Taiwan.
Facilities and healthcare providers using this product should contact Luminex Corporation for recall instructions and guidance.
The recalled product
- Product
- ARIES HSV 1&2 Assay, Part Number/REF 50-10017
- Manufacturer
- Luminex Corporation
- Hazard
- Affected units
- 296
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 (1)
- Lot number AB1703A
Distribution
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