FDA-Device2022-01-26Class II
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Luminex Corporation
Hazard
Impacted lot may leak inside the ARIES instrument.
Sold states
Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
Affected count
296 kits
Manufactured in
12212 Technology Blvd, N/A, Austin, TX, United States
Products
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2022Don't want to check this manually?
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