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 2C-25C 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.
Recall
- Recall Number
- Z-0699-2022
- Event Number
- 89446
- Firm
- Microbiologics Inc
- FEI Number
- 2150138
- Product Code
- OHQ
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- June 6, 2017
- Terminated
- January 17, 2023
- Address
- 200 Cooper Ave N, Saint Cloud, MN, 56303-4440
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 2C-25C 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.
Real-time shelf life testing failed at 24 months
Microbiologics notified customers on about 06/06/2017 via email containing a letter. The letters indicated the affected products and instructed customers to update their records with the corrected expiration date, which was provided for each affected lot.
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.
1 unit