Diagnostic test products recalled by Universal Meditech for missing FDA clearance
Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance 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 (risk-of-harm products) distributed without FDA marketing authorization and without verifiable Quality System compliance documentation. The recall is FDA Class II. No illnesses or injuries have been reported, so per the severity rubric, the score does not exceed 3.
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test products that were distributed without FDA marketing authorization. The recalled products include a breastmilk alcohol test strip, a SARS-CoV-2 antibody test, and ketone test strips. These products were distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and in Taiwan.
The company distributed these devices without FDA 510(k) clearance. Additionally, Universal Meditech Inc. cannot provide documentation that the devices were manufactured in conformance with FDA Quality System regulations. Specifically, the firm cannot provide Device History Files, documentation of controlled storage temperature and humidity, and post-market surveillance records such as adverse event reports and customer complaints.
Although the company claims to have purchased 510(k) authorizations from a previous device manufacturer in 2015, the FDA has not been able to verify this information or the existing documentation. As Universal Meditech Inc. is going out of business, the firm will be unable to fulfill post-market responsibilities for distributed products. No illnesses or injuries have been reported. Consumers should consult their healthcare provider or the FDA with any questions about these products.
The recalled product
- Product
- PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
- Manufacturer
- Universal Meditech Inc.
- Hazard
- missing-fda-clearance
- quality-system-non-compliance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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