Pregnancy Test Recalled Due to Quality Documentation Issues and Unauthorized Distribution
Universal Meditech Inc. is recalling DiagnosUS Pregnancy Test Midstream kits (3,304 units) due to inability to verify marketing authorization and missing quality documentation. The company, which is closing, cannot fulfill post-market safety 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: FDA Class II medical device recall. Company distributed the device without verified marketing authorization and lacks documentation of compliance with quality standards. While no illnesses or injuries are reported, the unknown performance characteristics of this diagnostic test represent risk-of-harm to users.
Plain-English summary
Universal Meditech Inc. is recalling DiagnosUS Pregnancy Test Midstream (Model 100-17) because the company cannot verify required marketing authorization and is unable to provide documentation of compliance with quality system regulations. The recall affects 3,304 tests manufactured after March 2021, distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan.
The company claims to hold FDA 510(k) clearances purchased from a previous holder in 2015, but the FDA has been unable to verify this information. Universal Meditech cannot provide evidence that the distributed devices comply with quality standards, including documentation that devices were not modified since original clearance, records of controlled storage conditions, and post-market surveillance data for complaints and adverse events. Because the devices' manufacturing and distribution history cannot be verified, their safety and effectiveness characteristics are unknown. The firm is going out of business and will be unable to fulfill post-market safety responsibilities.
The recalled product
- Product
- DiagnosUS Pregnancy Test Midstream REF 100-17
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unknown-performance
- unauthorized-marketing
- documentation-missing
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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