Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0699-2022)

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:

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.

Product Classification:

Class II

Date Initiated: June 6, 2017

Date Posted: March 9, 2022

Recall Number: Z-0699-2022

Event ID: 89446

Reason for Recall:

Real-time shelf life testing failed at 24 months

Status: Terminated

Product Quantity: 1 unit

Code Information:

Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023

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