Universal Meditech Recalls Ketone Test Strips for Unauthorized Distribution and Unknown Performance
Universal Meditech is recalling HealthyWiser KetoFast Ketone Test Strips because they were distributed without FDA authorization and lack documentation of proper manufacturing and quality control.
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 medical diagnostic device with unknown performance characteristics due to lack of manufacturing documentation and unverified FDA authorization. While no illnesses or injuries have been reported, the product poses a risk of harm because incorrect test results could affect healthcare decisions. This fits the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Universal Meditech Inc. is recalling HealthyWiser KetoFast Ketone Test Strips (model 900-1K, 150 test strips per box, lot number URS-1-2104-02). These diagnostic test strips are used to detect ketone levels.
The recall was initiated because the devices were distributed in the United States without FDA marketing authorization. The manufacturer claims to hold FDA clearances (510(k)s) for these devices but cannot provide documentation to verify this. The company states it purchased the intellectual property in 2015, but FDA has been unable to verify this information.
The company cannot provide documentation that the devices were manufactured in conformance with FDA's Quality System Regulation, including design history files (DHF) confirming the distributed devices were not modified since original clearance, records of controlled storage temperature and humidity, or post-market surveillance data such as complaints and adverse event reports. As a result, the devices may have unknown performance characteristics.
The affected products were distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming, as well as Taiwan. Universal Meditech is discontinuing business operations and cannot fulfill post-market safety responsibilities. Consumers who have purchased these test strips should stop using them and consult their healthcare provider if they have concerns about test results obtained with these strips.
The recalled product
- Product
- HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unknown-performance
- unauthorized-distribution
- quality-system-violation
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 (1)
- Model Number: 900-1K UDI-DI Code: Lot Numbers: URS-1-2104-02
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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