Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit con
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling one unit of Helix Elite Molecular Standards (Inactivated Respiratory Syncytial Virus A Strain Long, Catalog Number HE0028N, Lot Number HE0028N-102-1). The product failed real-time shelf life testing at 24 months, meaning it did not maintain its expected stability and performance characteristics through that time point.
The affected product was distributed worldwide to multiple U.S. states (including Alaska, California, Florida, New York, Texas, and others) as well as to Australia, Belgium, Canada, India, and the United Kingdom. The recall record does not specify what actions affected consumers should take in response to this recall.
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: 1 unit Lot/code info: Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.