Z-0784-2023 Class II Ongoing

Recalled by Biomerieux Inc — Hazelwood, MO

Recall Details

Product Type
Devices
Report Date
January 11, 2023
Initiation Date
November 9, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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

Distribution Pattern

US Nationwide distribution.

Code Information

UDI/DI 03573026047818, Batch Number 1009226560