Universal Meditech diagnostic test strips recalled for unauthorized distribution
Universal Meditech is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.
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 medical devices distributed without FDA marketing authorization and without documented compliance with Quality System regulations. No illnesses or injuries have been reported, but the devices are risk-of-harm products with unknown performance characteristics due to missing quality documentation. Per the severity rubric, risk-of-harm products without reported injury are scored at most 3 (High).
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test strips: the Lem Fertility LH Ovulation Test (REF 200-07), PrestiBio Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast Ketone Test Strips, and PrestiBio Ketone Test Strips. Approximately 12,500 tests were distributed across eight U.S. states (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan.
The recall was initiated because Universal Meditech distributed these products without required FDA marketing authorization. Additionally, the company is ceasing operations and will be unable to fulfill post-market responsibilities, including monitoring for adverse events and safety complaints. While the firm claims to hold 510(k) clearances for certain devices, FDA has been unable to verify this documentation.
FDA has determined that the company cannot provide documentation demonstrating manufacturing compliance with FDA's Quality System regulations. Missing documentation includes Device History Files showing the devices were not modified since original clearance, records of controlled storage temperatures and humidity, and post-market surveillance records of complaints and adverse events. As a result, the actual performance characteristics and safety of the distributed products cannot be verified.
The recalled product
- Product
- Lem Fertility LH Ovulation Test (Strip) REF 200-07
- Manufacturer
- Universal Meditech Inc.
- Hazard
- lack-of-authorization
- unknown-performance
- manufacturing-non-compliance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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