FDA-Device2022-04-27Class II

Inactivated macrolide-resistant Mycoplasma genitalium

Microbiologics Inc
Hazard

The QC process was not adequate for the specification range.

Sold states
US Nationwide distribution in the states of NV and VT.
Affected count
2 ea
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Inactivated macrolide-resistant Mycoplasma genitalium

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2022

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