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ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

FDA Recall #Z-0830-2023 — Class II — November 9, 2022

Recall #Z-0830-2023 Date: November 9, 2022 Classification: Class II Status: Ongoing

Product Description

ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

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

4 units

Distribution

US Nationwide distribution.

Code Information

UDI/DI 03573026378875, Batch Numbers: 1009434160

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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