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HARDY DIAGNOSTICS CatScreen, 25dsk/vial

FDA Recall #Z-0554-2022 — Class II — December 1, 2021

Recall #Z-0554-2022 Date: December 1, 2021 Classification: Class II Status: Terminated

Product Description

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

Reason for Recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

100 units (4 packs, 25 per pack)

Distribution

US Nationwide distribution in the state of California.

Code Information

Model Number HADZ110, all lots

Status

Terminated

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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