Recall Z-1740-2022— Microbiologics Inc

Name: FDA recall Z-1740-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-27

Class III · Terminated

Class III FDA medical device recall by Microbiologics Inc, initiated 2022-07-27, terminated 2024-08-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N. Reason: Product not registered for use in the UK.

Recalling firm: Microbiologics Inc
Classification: Class III
Status: Terminated
Initiated: 2022-07-27
Terminated: 2024-08-02
Firm location: Saint Cloud, MN, United States

Product description

Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

Reason for recall

Product not registered for use in the UK

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