FDA-Device2022-03-23Class II

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Microbiologics Inc
Hazard

Distributed product did not undergo proper release testing.

Sold states
Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam
Affected count
80 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Mycoplasma genitalium Control Panel (Inactivated Pellet)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0784-2022

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