Microbiologics Inc: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

Is my product affected?

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

• UPC 10845357042153

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 Neisseria gonorrhoeae Strain GL0071, Catalog Number HE0041N, Lot Number HE0041N-102-1) due to real-time shelf life testing that failed at 24 months. The product was distributed worldwide, including throughout numerous U.S. states and internationally to Australia, Belgium, Canada, India, and the United Kingdom.

The recall record does not specify a remedy or recommended action for affected consumers.

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 Lot/code info: Catalog Number: HE0041N; Lot Number: HE0041N-102-1; UDI: 10845357042153

Source

Official record: FDA (Device enforcement) ↗

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

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