ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
FDA Recall #Z-0823-2023 — Class II — November 9, 2022
Product Description
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Recalling Firm
Biomerieux Inc — Hazelwood, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026377557, Batch Numbers: 1009157090
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated