pH Test Strips Recalled for Unverified Manufacturing and Unknown Performance
Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.
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: FDA Class II medical device with undocumented manufacturing and unverified performance characteristics. While no illnesses or injuries have been reported, the devices pose a risk of harm due to unknown performance and inability to verify compliance with Quality System Regulations.
Plain-English summary
Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips (Model 900-1P, 120 strips per package) with lot numbers URS-1-2105-01-Q, URS-1-2105-02-Q, URS-1-2108-01-Q, URS-1-2109-01-Q, and URS-1-2111-01-Q. Approximately 13,000 test strips were distributed in the United States (California, Florida, Illinois, Louisiana, New Jersey, New York, Texas, and Wyoming) and Taiwan.
The devices were distributed without FDA marketing authorization. Universal Meditech Inc. is ceasing business operations and is unable to fulfill post-market responsibilities for these products. The FDA was unable to verify that the company holds valid marketing clearances (510(k)s) for these devices.
The manufacturer lacks documentation demonstrating that the devices were manufactured in accordance with FDA Quality System Regulations. Missing documentation includes evidence that devices were not modified since original clearance, records of controlled storage conditions, and post-market surveillance data such as complaints and adverse events. Consequently, the devices may have unknown performance characteristics and their safety and effectiveness cannot be verified.
The recalled product
- Product
- HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unknown-performance
- undocumented-manufacturing
- unverified-marketing-authorization
Distribution
Distributed in 8 states:
- CA
- FL
- IL
- LA
- NJ
- NY
- TX
- WY
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