FDA-Device2022-02-09Class II
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Luminex Corporation
Hazard
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
Sold states
Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.
Affected count
329
Manufactured in
12212 Technology Blvd, N/A, Austin, TX, United States
Products
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0553-2022Don't want to check this manually?
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