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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Distribution
Part of a larger recall action
This product is one of 27 recalled by Universal Meditech Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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