Z-0699-2022 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 unit
Product Description
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.
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: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023