Diagnostic test strips recalled for manufacturing non-compliance and unverified performance
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
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 a Class II recall for diagnostic medical devices with unverified safety and effectiveness due to missing documentation of manufacturing compliance and quality system records. While no illnesses or injuries have been reported, these are risk-of-harm products where device failures could affect patient diagnosis and treatment decisions.
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test strips distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan. The recalled products include HealthyWiser UriTest 10 Parameter Reagent Test Strips, PrestiBio Breastmilk Alcohol Test Strips, DiagnosUS SARS-CoV-2 Antibody Test Strips, and various Ketone Test Strips. Approximately 122,500 test strips are affected.
The recall is due to the company's inability to provide documentation that the devices were manufactured in compliance with federal Quality System Regulations. Universal Meditech cannot provide device specifications, records of manufacturing controls, documentation of controlled storage conditions, or post-market surveillance documentation such as complaints and adverse events. This means the safety and effectiveness of these devices cannot be verified.
Additionally, some of these devices were distributed without proper marketing authorization. Universal Meditech has announced it is ceasing operations and will not be able to fulfill post-market responsibilities for these products.
Consumers and healthcare providers who possess these test strips should discontinue use and discard them appropriately. If you have relied on results from these test strips for medical decisions, contact your healthcare provider.
The recalled product
- Product
- HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unverified-performance
- product-defect
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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