ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
FDA Recall #Z-0812-2023 — Class II — November 9, 2022
Product Description
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
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 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated