One Step Pregnancy Test Recalled for Unverified FDA Marketing Authorization
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
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: Class II medical device recall of pregnancy test with unverified marketing authorization and missing quality documentation. This is a risk-of-harm medical device with unknown performance characteristics, but no illnesses or injuries have been reported.
Plain-English summary
Universal Meditech Inc. is recalling approximately 147,000 One Step Pregnancy Tests (Model REF 100-01) distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan. The devices carry UDI-DI Code B512100011 and are identified by lot numbers 3-H25052-20UMI and 3-H07102-20UMI.
The FDA classified this as a Class II recall because Universal Meditech was distributing the pregnancy test without verified marketing authorization. Although the manufacturer claims to hold FDA 510(k) clearance and states it purchased the intellectual property in 2015, the FDA has been unable to independently verify this information.
Universal Meditech is ceasing business operations and cannot continue to fulfill post-market responsibilities including safety surveillance and adverse event reporting. The company cannot provide required documentation demonstrating the devices comply with FDA Quality System regulations, including device history files, controlled storage records, and post-market safety data.
Due to these gaps, the pregnancy tests may have unknown performance characteristics. Without documented manufacturing history, verified clearance status, and controlled storage conditions, the safety and effectiveness of these tests cannot be assured.
The recalled product
- Product
- One Step Pregnancy Test REF 100-01
- Manufacturer
- Universal Meditech Inc.
- Affected units
- 147,000
Distribution
Part of a larger recall action
This product is one of 27 recalled by Universal Meditech Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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