Diagnostic Test Strips Recalled Due to Manufacturing Documentation Failures and Company Closure
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
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: These are diagnostic test devices with unknown performance characteristics due to lack of manufacturing and quality system documentation. While classified as FDA Class II recall with no reported illnesses or injuries, the devices present a risk of harm through potentially incorrect test results, which could impact patient health decisions.
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test products that were distributed without proper marketing authorization. The products being recalled include PrestiBio Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast Ketone Test Strips, and PrestiBio Ketone Test Strips.
The recall was initiated because Universal Meditech Inc. is going out of business and cannot fulfill post-market responsibilities for these products. More significantly, the company is unable to provide documentation that these devices were manufactured in conformance with FDA's Quality System Regulation. Critical missing documentation includes Device History Files, records of manufacturing controls, controlled storage temperature and humidity conditions, and post-market surveillance data such as consumer complaints and adverse event reports.
Because of these documentation gaps, the actual performance characteristics and safety of these devices cannot be verified. While the company claims to hold 510(k) approvals for some devices, the FDA has been unable to verify these claims or confirm that the distributed devices were not modified in ways that could affect their safety or effectiveness.
Consumers and healthcare providers who have obtained these test products should discontinue use immediately. If you have previously used these devices and have concerns about your test results, consult with a healthcare provider.
The recalled product
- Product
- One Step Ovulation Test REF 200-01
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unverified-performance
- manufacturing-non-compliance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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