Pregnancy Test Cassettes Recalled for Unverified Performance and Authorization
Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.
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 FDA Class II recall involves an unverified medical device with missing manufacturing and quality documentation. No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed. Per the severity rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Universal Meditech Inc. is recalling DeTec hCG Pregnancy Urine Test Cassette Format (Model 100-13). Approximately 4,103 cassettes were distributed in the United States in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming, as well as Taiwan. Affected lot numbers include hCG-M5-2101-01, hCG-M5-2104-01, hCG-M5-2106-01, hCG-M5-2107-01, hCG-M5-2108-01, hCG-M5-2110-01, hCG-M5-2202-01, hCG-M5-2202-02, hCG-M5-2202-03, hCG-M5-2203-01, hCG-M5-2204-01, hCG-M5-2204-02, hCG-M5-2204-03, hCG-M5-2206-01, hCG-M5-2206-02, hCG-M5-2207-01, and hCG-M5-2210-02.
The FDA issued this recall because the devices were distributed without verified marketing authorization. Universal Meditech Inc. claims to hold 510(k) clearances but cannot provide documentation to support this claim. The firm also lacks critical manufacturing documentation required by FDA regulations, including Device History Files and records showing conformance with Quality System regulations. Additionally, there is no documentation of controlled storage conditions and no post-market surveillance data such as adverse event reports or customer complaints.
Because the devices' performance characteristics cannot be independently verified and the manufacturer is closing its operations, it cannot fulfill post-market responsibilities to address any safety issues that may arise. Consumers who have purchased these test cassettes should not use them and should consult their healthcare provider or pharmacist for alternative testing options.
The recalled product
- Product
- DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unverified-performance
- missing-quality-documentation
- manufacturing-compliance-failure
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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