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Terminated

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.

FDA Recall Z-0699-2022 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeOHQ
Date Initiated2017-06-06
Date Terminated2023-01-17
Product Quantity1 unit

Reason for Recall

Real-time shelf life testing failed at 24 months

Firm Action

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.

Root Cause

Process design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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