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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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