DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
FDA Recall #Z-0869-2023 — Class II — November 9, 2022
Product Description
DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
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
14 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03661901000857, Batch Numbers: 3073090
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated