ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445

FDA Recall #Z-0841-2023 — Class II — November 9, 2022

Recall #Z-0841-2023 Date: November 9, 2022 Classification: Class II Status: Ongoing

Product Description

ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445

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

6 units

Distribution

US Nationwide distribution.

Code Information

UDI/DI 03573026418748, Batch Numbers: 1009420460

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated