High FDA (Devices)·Z-0554-2022·Announced 2022-02-09

HARDY DIAGNOSTICS CatScreen diagnostic kit recalled due to improper storage

HARDY DIAGNOSTICS CatScreen test kits (Model HADZ110) are recalled because units were stored in temperature-controlled settings instead of refrigeration. Improper storage may compromise product effectiveness.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall indicates potential for adverse health consequences. This is a risk-of-harm diagnostic product where improper storage may affect test accuracy and reliability, but no illnesses or injuries have been reported. Per the rubric, Class II recalls without reported adverse events score at most 3 (High).

Plain-English summary

HARDY DIAGNOSTICS CatScreen, 25dsk/vial (Model HADZ110), a diagnostic test kit manufactured by MEDLINE INDUSTRIES, LP of Northfield, is being recalled.

The recall was initiated because the product was stored in a temperature-controlled setting instead of being stored under refrigeration as required. Improper storage conditions may affect product integrity and diagnostic reliability.

Approximately 100 units (distributed as 4 packs of 25 disks each) were distributed in California. Consumers who have purchased this product should not use it and should contact their healthcare provider or MEDLINE INDUSTRIES for guidance on replacement or return instructions.

The recalled product

Product: HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Diagnostic Test Kit
Hazard: temperature-storage
product-degradation
diagnostic-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Model Number HADZ110
all lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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