FDA Recalls Pregnancy Test Cassettes Due to Unverified Manufacturing
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
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 recall with no reported illnesses or injuries. The hazard is theoretical—unknown performance characteristics due to unverified manufacturing and missing Quality System documentation. Per the rubric, risk-of-harm products without documented injury qualify as High (3).
Plain-English summary
Universal Meditech Inc. is recalling approximately 25,000 DiagnosUS hCG Pregnancy Urine Test Cassette Format units (Model 100-13) distributed in eight U.S. states (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan. The recall affects all products manufactured after March 2021.
The devices were distributed without FDA marketing authorization. Universal Meditech Inc. is also ceasing operations and cannot fulfill post-market responsibilities for monitoring complaints and adverse events.
The company claims to hold FDA 510(k) clearances but the FDA has been unable to verify this claim. Universal Meditech lacks documentation that the devices were manufactured in compliance with FDA Quality System regulations, including device master files and records of controlled storage temperature and humidity.
Because Universal Meditech cannot provide manufacturing documentation, the devices may have unknown performance characteristics and their safety and effectiveness cannot be verified.
The recalled product
- Product
- DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- no-market-authorization
- unknown-performance-characteristics
- quality-system-violation
- missing-post-market-surveillance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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