Device product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Z-0701-2022
Product summary
- Event
- Event 89446
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0701-2022
Official wording
Reason: Real-time shelf life testing failed at 24 months
Code information: Catalog Number: HE0044N; Lot Number: HE0044N-103-1; UDI: 10845357042184
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
Derived failure modes
-
Unknown
Real-time shelf life testing failed at 24 months