FDA Recalls Multiple Unauthorized Diagnostic Test Products by Universal Meditech
Universal Meditech Inc. is recalling diagnostic tests distributed without FDA authorization and lacking required quality system documentation. The company is ceasing operations and cannot fulfill post-market responsibilities.
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 FDA Class II recall of diagnostic devices distributed without marketing authorization and lacking required quality system documentation. No illnesses or injuries have been reported, but unauthorized distribution and unknown performance characteristics of diagnostic tests create a risk of harm if they provide inaccurate results.
Plain-English summary
Universal Meditech Inc. is recalling four diagnostic test products that were distributed without FDA marketing authorization. The recalled products are the PrestiBio Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast Ketone Test Strips, and PrestiBio Ketone Test Strips.
The products were distributed violatively without the required FDA marketing authorization. Universal Meditech Inc. claims to hold 510(k) clearances but cannot provide documentation that the FDA can verify. The devices may have unknown performance characteristics because the company lacks required quality system documentation.
The company cannot provide documentation showing that the devices were manufactured in compliance with FDA Quality System Regulations, including Design History Files showing whether devices were modified since original clearance, records of controlled storage conditions, and post-market surveillance data such as customer complaints and adverse events.
Universal Meditech Inc. is ceasing business operations and cannot fulfill post-market safety and surveillance responsibilities. Consumers who possess these products should consult their healthcare provider for guidance on continued use or proper disposal.
The recalled product
- Product
- PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
- Manufacturer
- Universal Meditech Inc.
- Hazard
- inaccurate-test-result
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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