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Z-0754-2026Class II

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What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
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Product type
Device
Status
Ongoing
Report date
2025-12-10
Distribution
US Nationwide distribution.
Product quantity
40 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Distribution without premarket approval/clearance.

Product description

Urinary Tract Infection Test

Code / lot info

EAN: 7340221700529; SKU: A-URI; UDI-DI: None; Lot/Serial Number: All Lots;

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →