Pregnancy Test Cassettes Recalled for Unknown Performance Characteristics
Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.
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 recall with no reported illnesses or injuries and theoretical hazard. The unknown performance characteristics of a pregnancy test represent a risk-of-harm product where injury has not yet been reported, meeting criteria for High severity.
Plain-English summary
Universal Meditech Inc. is recalling 1,000 DiagnosUS hCG Pregnancy Serum/Urine Test Cassettes (Model 100-27) distributed to California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming, and Taiwan. The recall applies to all products manufactured after March 2021.
The devices were distributed without FDA marketing authorization. The manufacturer is ceasing operations and cannot meet post-market responsibilities. The FDA was unable to verify the manufacturer's claimed 510(k) clearances for these devices.
These devices may have unknown performance characteristics. The manufacturer cannot provide documentation of manufacturing compliance with FDA's Quality System Regulation. This includes missing evidence that the distributed devices were not modified since original clearance, documentation of controlled storage conditions, and post-market surveillance data such as complaints and adverse events.
Consumers who have purchased these test cassettes should stop using them and contact a healthcare provider.
The recalled product
- Product
- DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- unknown-performance
- quality-system-violation
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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