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

Is my product affected?

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

• UPC 10845357042184

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling one unit of Helix Elite Molecular Standards (Inactivated Standard) containing inactivated Influenza A/B and Respiratory Syncytial Virus. The product, identified by Catalog Number HE0044N and Lot Number HE0044N-103-1, is being recalled because real-time shelf life testing failed at 24 months. The affected unit was distributed worldwide, including to numerous U.S. states and several countries including Australia, Belgium, Canada, India, and the United Kingdom.

The recall record does not specify a remedy or any actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Real-time shelf life testing failed at 24 months

Details from the source

Reason for recall: Real-time shelf life testing failed at 24 months Distribution: 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. Quantity: 1 unit Lot/code info: Catalog Number: HE0044N; Lot Number: HE0044N-103-1; UDI: 10845357042184

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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