Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0697-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 6, 2017

Date Posted: March 9, 2022

Recall Number: Z-0697-2022

Event ID: 89446

Reason for Recall:

Real-time shelf life testing failed at 24 months

Status: Terminated

Product Quantity: 8 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated