Microbiologics QC Sets and Panels: Helix Elite recalled over E. coli risk

Recall date

June 6, 2017

Source

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

Official notice title

Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) incl…

Recall number

Z-0697-2022

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

Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209