Z-0700-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- June 6, 2017
- Termination Date
- January 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Reason for Recall
Real-time shelf life testing failed at 24 months
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.
Code Information
Catalog Number: HE0041N; Lot Number: HE0041N-102-1; UDI: 10845357042153