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Recall Observatory FDA recall evidence

Device product

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus

Z-0701-2022

June 06, 2017

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 89446
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0701-2022

Official wording

Reason: Real-time shelf life testing failed at 24 months

Code information: Catalog Number: HE0044N; Lot Number: HE0044N-103-1; UDI: 10845357042184

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Real-time shelf life testing failed at 24 months