FDA-Device2022-03-09Class II
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Microbiologics Inc
Hazard
Real-time shelf life testing failed at 24 months
Sold states
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.
Affected count
1
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0700-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief