FDA recall Z-0553-2022

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-11-17

Report date

2022-02-09

Termination date

2024-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0553-2022