Z-0697-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- June 6, 2017
- Termination Date
- January 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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
Reason for Recall
Real-time shelf life testing failed at 24 months
Distribution Pattern
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.
Code Information
Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240