Unauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
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 an FDA Class II recall of devices distributed without marketing authorization and with unverified Quality System compliance. Although no illnesses or injuries have been reported, the devices pose an unknown risk due to undocumented manufacturing and storage conditions, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Universal Meditech Inc. is recalling multiple diagnostic test kits: PrestiBio Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast Ketone Test Strips, and PrestiBio Ketone Test Strips. The recall affects 2,500 tests distributed across the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, Wyoming) and Taiwan, with all products manufactured after March 2021.
The recall was initiated because Universal Meditech Inc. distributed these devices without FDA marketing authorization. The manufacturer is also ceasing operations and cannot fulfill post-market responsibilities for the distributed products.
The company claims to hold FDA 510(k) clearances for these devices, stating it purchased the intellectual property from the previous 510(k) holder in 2015. However, the FDA has been unable to verify this claim. The primary concern is that Universal Meditech Inc. cannot provide documentation proving the devices were manufactured in conformance with FDA Quality System regulations. This includes design history files, evidence that distributed devices were not modified since original clearance in ways affecting safety and effectiveness, records of controlled storage conditions, and post-market surveillance data such as complaints and adverse events.
Because the manufacturer cannot provide this critical documentation, the actual safety and effectiveness of these distributed devices remain unknown. Consumers should not rely on results from these test kits and should seek proper medical testing through healthcare providers.
The recalled product
- Product
- Lem Fertility hCG Pregnancy Urine Test REF 100-12
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unauthorized-distribution
- unknown-performance
- documentation-deficiency
- quality-system-non-compliance
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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