FDA recall Z-0498-2022

Product

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

Reason for recall

Impacted lot may leak inside the ARIES instrument.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-04-16

Report date

2022-01-26

Termination date

2024-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2022