Diagnostic Test Strips Recalled for Manufacturing Conformance and Documentation Issues
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or 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 tests with unverified manufacturing compliance and unknown performance characteristics. Although no illnesses or injuries are documented, diagnostic test failures could lead to missed or incorrect diagnoses. The missing post-market surveillance capability and manufacturer closure eliminate the ability to detect performance issues after distribution.
Plain-English summary
Universal Meditech Inc. is recalling the DiagnosUS™ One Step FSH Menopausal Test (Strip) Model 210-07. Approximately 2,400 tests have been distributed to consumers in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan. The affected lot numbers are FSH-S-2106-01, FSH-S-2108-01, and FSH-S-2111-01-S, manufactured from March 2021 onward.
The manufacturer initiated this recall because the company is ceasing business operations and cannot fulfill post-market responsibilities for these products, including adverse event monitoring and complaint investigation. The FDA classified this as a Class II recall because Universal Meditech cannot provide required documentation proving the devices were manufactured according to FDA Quality System regulations. Missing documentation includes controlled storage temperature and humidity records, device modification history since original clearance, and post-market surveillance data.
Universal Meditech claims to hold 510(k) market clearance for these devices but the FDA has been unable to verify this. Without required Quality System documentation, the actual performance characteristics of the test strips remain unknown and cannot be verified. Consumers in possession of these test strips should be aware that the reliability of results cannot be confirmed due to the missing manufacturing documentation and lack of post-market surveillance.
The recalled product
- Product
- DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unknown-performance
- quality-system-violation
- missing-post-market-surveillance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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