Microbiologics Inc recalls Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target p…

Recall date

June 6, 2017

Source

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

Recall number

Z-0699-2022

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 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.