Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
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 is an FDA Class II recall with no reported illnesses or injuries. However, it qualifies as high-risk because the product is a medical diagnostic test critical to healthcare decision-making, and the manufacturer cannot demonstrate manufacturing compliance or provide documentation of product quality system adherence, creating theoretical risk of unreliable test results.
Plain-English summary
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test REF 100-17. Approximately 45,420 tests are affected across multiple lot numbers.
The recall is due to the company's closure and inability to fulfill post-market responsibilities. The FDA has been unable to verify the company's manufacturing authorization claims or confirm that the devices were manufactured in compliance with FDA Quality System regulations. The manufacturer has not provided documentation of controlled storage and handling conditions, manufacturing conformance to regulatory standards, or post-market surveillance data such as adverse event reports.
The affected pregnancy tests were distributed in the United States to California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming, as well as internationally to Taiwan. Consumers and healthcare providers who have these tests should consult with a healthcare provider regarding the reliability of test results.
The recalled product
- Product
- Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Pregnancy Test
- Affected units
- 45,420
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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