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 (ST
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling its Helix Elite Extended Enteric Bacterial Verification Panel (Inactivated Pellet), which contains 21 pellets comprised of 8 organisms used for quality control testing. The recall affects 8 units with Catalog Number 8191, Lot Number 8191-01, and UDI 70845357041240. Real-time shelf life testing of the product failed at 24 months, prompting the recall.
The recalled product was distributed worldwide and in the United States to customers in Alaska, California, Washington D.C., Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia, as well as to Australia, Belgium, Canada, India, and the United Kingdom. The recall record does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Real-time shelf life testing failed at 24 months
Reason for recall: Real-time shelf life testing failed at 24 months Distribution: 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. Quantity: 8 units Lot/code info: Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.