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

Recalled March 9, 2022 · FDA recall Z-0699-2022 · Microbiologics

Hazard

Real-time shelf life testing failed at 24 months · FDA Class II

Units

1 unit

Sold at

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.

Description

Real-time shelf life testing failed at 24 months

Product

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.

Manufacturer(s)

Microbiologics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →