Pregnancy test strips recalled for lack of FDA authorization and quality documentation
Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: No illnesses or injuries have been reported. The hazard is theoretical—the company cannot verify proper manufacturing and quality system compliance—making this a precautionary recall due to documentation gaps and business closure, not a confirmed product defect.
Plain-English summary
Universal Meditech Inc. is recalling DiagnosUS hCG Pregnancy Urine Test Strip Format (Model 100-12). Approximately 5,025 units were distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan. Products manufactured after March 2021 are affected, including lots hCG-S-2101-01, hCG-S-2111-01-S, and hCG-S-2112-01.
The recall was issued because Universal Meditech Inc. distributed these tests without FDA marketing authorization. The company is ceasing operations and stated it cannot continue to fulfill post-market surveillance responsibilities. Additionally, the FDA was unable to verify the company's claims of holding valid 510(k) clearances, and the company cannot provide documentation that the devices were manufactured in accordance with FDA Quality System regulations.
The company lacks documentation demonstrating that devices were not modified since original clearance, records of controlled storage conditions, and post-market surveillance data such as customer complaints and adverse event reports. Without this documentation, the performance and safety characteristics of the distributed tests cannot be independently verified.
The recalled product
- Product
- DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unapproved-marketing
- unverified-performance
- quality-system-non-compliance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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