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Recall Observatory FDA recall evidence

Device product

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

Z-0498-2022

April 16, 2021

Class II

Product summary

Firm
Luminex Corporation
Event
Event 89303
Status
Terminated
Classification
Class II
Quantity
296 kits
Official record key
device-enforcement:Z-0498-2022

Official wording

Reason: Impacted lot may leak inside the ARIES instrument.

Code information: Lot number AB1703A

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Impacted lot may leak inside the ARIES instrument.