UTI Test Strips Recalled for Lack of Quality Documentation and Compliance Verification
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
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: This is an FDA Class II medical device recall where no illnesses or injuries have been reported. The hazard—unknown performance characteristics due to unverified manufacturing compliance—is theoretical rather than realized. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips (REF 900-UTI) due to the manufacturer's inability to provide documentation proving the devices were manufactured in compliance with FDA Quality System regulations. The recall affects 5,960 test strips distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan.
The manufacturer cannot provide Device History File documentation, controlled storage condition records, or post-market surveillance documentation required to verify device safety and effectiveness. Universal Meditech Inc. is discontinuing operations and will be unable to fulfill ongoing post-market responsibilities.
The devices may have unknown performance characteristics due to unverified manufacturing compliance. Consumers with HealthyWiser UriTest™ test strips bearing lot numbers URS-1-2102-03, URS-1-2106-01, URS-1-2202-01-Q, URS-1-2204-01, URS-1-2207-01, or URS-1-2209-01 should stop using them and consult their healthcare provider or contact Universal Meditech Inc. for further guidance.
The recalled product
- Product
- HealthyWiser UriTest" UTI Test Strips REF 900-UTI
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unknown-performance-characteristics
- quality-non-compliance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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