Ketone Test Strips Recalled for Lack of FDA Marketing Authorization
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
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 FDA Class II recall involves diagnostic devices distributed without marketing authorization and unverified quality system compliance. Although no illnesses or injuries have been reported, ketone test strips with unknown performance characteristics represent a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score per the rubric.
Plain-English summary
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips (Model 900-1KET) after determining they were distributed without FDA marketing authorization. All products manufactured after March 2021 are included in this recall.
The company distributed these diagnostic devices in violation of FDA regulations requiring marketing authorization. Universal Meditech Inc. is also going out of business and therefore unable to fulfill post-market responsibilities for these devices. The FDA was unable to verify the company's claims to hold FDA clearances or to confirm that devices were manufactured in compliance with FDA Quality System regulations. Without proper documentation of manufacturing conformance, the devices may have unknown performance characteristics.
The recalled test strips were distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming, as well as internationally to Taiwan.
Consumers who have purchased these test strips should stop using them and consult their healthcare provider for appropriate ketone testing alternatives.
The recalled product
- Product
- PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
- Manufacturer
- Universal Meditech Inc.
- Hazard
- uncleared-device
- unknown-performance
- inaccurate-results
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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