PrestiBio Urinalysis Test Strips Recalled for Unverified Manufacturing
Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.
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: The devices are risk-of-harm products with unknown performance characteristics caused by missing manufacturing documentation and Quality System Regulation compliance failures. No illnesses or injuries are reported in the source, meeting the criteria for Score 3 (High) per the severity rubric.
Plain-English summary
Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10, a diagnostic urinalysis test strip distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan. The recall affects all products manufactured after March 2021.
The devices are being recalled because the firm cannot provide required manufacturing documentation demonstrating compliance with FDA quality standards. Universal Meditech is unable to furnish device history files, Quality System Regulation documentation, controlled storage records, or post-market surveillance data. As a result, the devices may have unknown performance characteristics and the firm cannot verify they are safe and effective.
Additionally, the firm was distributing these devices without marketing authorization and is ceasing operations. The firm states it cannot fulfill post-market responsibilities including monitoring for safety issues or responding to adverse events.
Consumers and healthcare providers who have these test strips should discontinue use. If you have questions, contact Universal Meditech Inc. or consult your healthcare provider.
The recalled product
- Product
- PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
- Manufacturer
- Universal Meditech Inc.
Distribution
Part of a larger recall action
This product is one of 27 recalled by Universal Meditech Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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