DiagnosUS Ovulation Predictor test recalled due to unverified manufacturing documentation
Universal Meditech Inc. is recalling DiagnosUS Ovulation Predictor Midstream devices due to lack of FDA marketing authorization and inability to verify manufacturing compliance. The manufacturer is ceasing operations.
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 a Class II recall for a diagnostic device with unverified performance characteristics and inadequate Quality System compliance documentation. Although no illnesses or injuries have been reported, it is a risk-of-harm product where safety and effectiveness cannot be verified. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Universal Meditech Inc. is recalling the DiagnosUS Ovulation Predictor Midstream (Model 200-17). Approximately 3,600 tests were distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan. All lots manufactured after March 2021 are affected.
The company distributed this device without FDA marketing authorization. Universal Meditech Inc. is ceasing operations and will be unable to continue fulfilling post-market responsibilities. Although the company claims to hold a 510(k) clearance and purchased the intellectual property from a previous clearance holder in 2015, the FDA has been unable to verify this information.
The device may have unknown performance characteristics. The company cannot provide documentation that it was manufactured according to FDA Quality System regulations, including Device History File records, documentation of controlled storage conditions, or post-market surveillance data such as customer complaints and adverse event reports.
The recalled product
- Product
- DiagnosUS Ovulation Predictor Midstream REF 200-17
- Manufacturer
- Universal Meditech Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unverified-performance
- inadequate-quality-control
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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