medical Class II Updated 2022-03-09

Microbiologics Inc recalls Helix Elite" Molecular Standards: Inactivated Standard. Ina

Recalled Product

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 contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


Hazard / Issue

Real-time shelf life testing failed at 24 months

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023
View official government recall

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