Recall Z-0955-2022— Microbiologics Inc

Name: FDA recall Z-0955-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-22

Class II · Terminated

Class II FDA medical device recall by Microbiologics Inc, initiated 2022-03-22, terminated 2023-01-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Inactivated macrolide-resistant Mycoplasma genitalium. Reason: The QC process was not adequate for the specification range..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Terminated
Initiated: 2022-03-22
Terminated: 2023-01-09
Firm location: Saint Cloud, MN, United States

Product description

Inactivated macrolide-resistant Mycoplasma genitalium

Reason for recall

The QC process was not adequate for the specification range.

Data sourced from openFDA. This site is unofficial and independent of the FDA.