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Recall Observatory FDA recall evidence

Device product

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

Z-0553-2022

November 17, 2021

Class II

Product summary

Firm
Luminex Corporation
Event
Event 89244
Status
Terminated
Classification
Class II
Quantity
329
Official record key
device-enforcement:Z-0553-2022

Official wording

Reason: 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.

Code information: Lot Numbers AB3600A and AB3560A

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.