Z-0498-2022 Class II Terminated
FDA device recall Z-0498-2022 was initiated by Luminex Corporation on April 16, 2021 and is designated Class II. Reason for recall: Impacted lot may leak inside the ARIES instrument. The recall status is terminated (terminated September 20, 2024). Affected quantity: 296 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- April 16, 2021
- Termination Date
- September 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 296 kits
Product Description
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Reason for Recall
Impacted lot may leak inside the ARIES instrument.
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.
Code Information
Lot number AB1703A