API 20 E 25 STRIPS, CATALOG 20100
FDA Recall #Z-0784-2023 — Class II — November 9, 2022
Product Description
API 20 E 25 STRIPS, CATALOG 20100
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
1 unit
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026047818, Batch Number 1009226560
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated