Device product

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Z-0784-2022

February 25, 2022

Class II

Product summary

Firm: Microbiologics Inc
Event: Event 89694
Status: Terminated
Classification: Class II
Quantity: 80 units
Official record key: device-enforcement:Z-0784-2022

Official wording

Reason: Distributed product did not undergo proper release testing.

Code information: Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Distributed product did not undergo proper release testing.