Device product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Z-0498-2022
Product summary
- 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
Impacted lot may leak inside the ARIES instrument.