FDA recall Z-0784-2022

Product

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Reason for recall

Distributed product did not undergo proper release testing.

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-02-25

Report date

2022-03-23

Termination date

2024-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

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