Pregnancy test strips recalled due to manufacturing documentation gaps
Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.
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: Class II recall of a pregnancy diagnostic device with unverified manufacturing compliance and missing quality system documentation. Although no illnesses or injuries have been reported, pregnancy tests are risk-of-harm products where performance cannot be verified, meeting the High severity criterion.
Plain-English summary
Universal Meditech Inc. is recalling To Life hCG Pregnancy Urine Test Strips (model 100-13, lot hCG-S-2210-03) distributed in California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming in the U.S., and Taiwan internationally.
The company is ceasing business operations and cannot fulfill post-market responsibilities for these devices. Additionally, Universal Meditech Inc. cannot provide documentation verifying that the devices were manufactured in compliance with FDA Quality System regulations. The firm is unable to provide design history files, manufacturing control documentation, records of controlled storage conditions, or post-market surveillance documentation such as customer complaints and adverse events.
As a result, the performance and safety characteristics of these test strips cannot be verified. The devices may have unknown performance characteristics due to the lack of manufacturing and quality documentation.
Consumers who have purchased this product should be aware of these verification issues. Anyone with questions about whether their product is affected or who has concerns about test results should contact Universal Meditech Inc. or consult a healthcare provider.
The recalled product
- Product
- To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unknown-performance
- unverified-manufacturing
- missing-documentation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 100-13 UDI-DI Code: None Lot Numbers: hCG-S-2210-03
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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