Microbiologics Inc recalls Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

Recall date

June 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0700-2022

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

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.

Why it was recalled

Real-time shelf life testing failed at 24 months

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.