Device 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
Z-0697-2022
Product summary
- Event
- Event 89446
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0697-2022
Official wording
Reason: Real-time shelf life testing failed at 24 months
Code information: Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240
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.
Derived failure modes
-
Unknown
Real-time shelf life testing failed at 24 months