FDA recall Z-1740-2022

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 for recall

Product not registered for use in the UK

Distribution

International distribution to the country of United Kingdom.

Key facts

Status

Terminated

Initiation date

2022-07-27

Report date

2022-09-21

Termination date

2024-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2022