API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
FDA Recall #Z-0786-2023 — Class II — November 9, 2022
Product Description
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
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 03573026048259, Batch Number 1009395530
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated