FDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
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: FDA Class II medical device with completely unverified manufacturing compliance and missing post-market surveillance documentation. Although no illnesses or injuries are reported, this qualifies as a risk-of-harm product where injury has not yet been reported, meeting criteria for High severity.
Plain-English summary
Universal Meditech Inc. is recalling the DiagnosUS One Step LH Ovulation Test Strip (Model 200-07). Approximately 525 devices were distributed in the United States, including California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming, as well as Taiwan.
The manufacturer cannot document that these devices were manufactured in accordance with FDA quality system regulations. Universal Meditech Inc. has not provided documentation proving the devices were manufactured in conformance with regulatory requirements, including Device History Files, controlled storage condition records, and post-market surveillance documentation. The company was distributing this test product without proper FDA verification of marketing authorization.
Universal Meditech Inc. is ceasing operations and will be unable to fulfill post-market responsibilities for these products. The performance characteristics of the devices cannot be independently verified.
There are no reported injuries or illnesses from these test strips to date. Consumers in possession of these products should consult with their healthcare provider about whether to continue use or switch to an alternative ovulation diagnostic test.
The recalled product
- Product
- DiagnosUS One Step LH Ovulation Test Strip REF 200-07
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unverified-performance
- missing-documentation
- quality-system-deficiency
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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