SARS-CoV-2 Antibody Test Recalled Due to Manufacturing Compliance Issues
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
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 a diagnostic medical device where the manufacturer cannot verify safety and effectiveness characteristics due to lack of manufacturing documentation and quality system compliance verification. No illnesses or injuries have been reported. This meets the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10. Approximately 1,000 test units were distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan.
The devices were distributed without proper FDA marketing authorization. The manufacturer is ceasing operations and cannot fulfill post-market responsibilities. The FDA has been unable to verify the firm's claims regarding valid 510(k) authorizations. Because the manufacturer cannot provide documentation of manufacturing compliance with Quality System regulations—including controlled storage conditions, device specifications, and post-market complaint tracking—the actual safety and effectiveness characteristics of the distributed tests remain unknown.
Consumers who possess these tests should not use them and should contact their healthcare provider for guidance. Healthcare facilities that have received these devices should segregate remaining inventory and not use them.
The recalled product
- Product
- DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unauthorized-distribution
- unknown-performance
- quality-system-violation
- undocumented-storage
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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