Recall Z-0700-2022— Microbiologics Inc

Name: FDA recall Z-0700-2022
Creator: U.S. Food and Drug Administration
Published: 2017-06-06

Class II · Terminated

Class II FDA medical device recall by Microbiologics Inc, initiated 2017-06-06, terminated 2023-01-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.. Reason: Real-time shelf life testing failed at 24 months.

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Terminated: 2023-01-17
Firm location: Saint Cloud, MN, United States

Product description

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

Reason for recall

Real-time shelf life testing failed at 24 months

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