Evidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
Randox Laboratories is recalling 40 units of the Evidence MultiSTAT analyzer because a foam gasket defect may allow light to leak into the camera during testing, potentially affecting result accuracy and delaying reporting.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III device with a functional defect affecting test accuracy and operational efficiency. No illnesses, injuries, or deaths reported. The hazard is operational degradation (light leakage causing inaccurate results) rather than a physical safety threat to users.
Plain-English summary
Randox Laboratories Ltd. is recalling the Evidence MultiSTAT with software v 3.7-Analyzer (Catalog Number EV4115), a device used to detect parent drug molecules and metabolites in human urine samples. The recall involves 40 units that were distributed nationwide in the United States.
The foam gasket on the chip heater assembly may not function as designed. When the gasket fails to perform as expected, light can leak into the Charged Coupled Device (CCD) Camera during imaging. Light entering the camera compromises the testing process and may delay the reporting of results.
Laboratories and healthcare facilities using the affected serial numbers should stop using the device and contact Randox Laboratories for instructions on replacement or repair. The specific serial numbers involved are listed in the FDA recall notice.
The recalled product
- Product
- Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 40
Distribution
Distributed nationwide across the United States.
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