FDA recall Z-0795-2023

Biomerieux Inc · Class II · device

Product

VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-11-09
Report date
2023-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0795-2023