VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
FDA Recall #Z-0868-2023 — Class II — November 9, 2022
Product Description
VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
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
47 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026223601, Batch Numbers: 1009301530
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated