medical Class II Updated 2022-03-09

Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Ent

Recalled Product

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

Hazard / Issue

Real-time shelf life testing failed at 24 months

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240
View official government recall

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