Quest International recalled 376 Measles IgM Test Kits on July 17, 2025. The kits lack premarket approval or clearance from the FDA. Healthcare providers and patients must stop using these kits immediately.
Measles IgM Test Kit lacks premarket approval or clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Quest International, Inc. or your healthcare provider for instructions. Notification method: Letter
The recalled product is the Measles IgM Test Kit, model number 01-190M. It was distributed nationwide in Utah, Texas, and Arizona. The quantity recalled is 376 kits.
The Measles IgM Test Kit does not have the necessary premarket approval or clearance. This lack of approval means the product may not be safe or effective for its intended use.
No incidents or injuries have been reported related to this product recall. However, the absence of required approval raises significant safety concerns.
Stop using the Measles IgM Test Kit immediately. Follow the manufacturer’s recall instructions and contact Quest International or your healthcare provider for further instructions.
For more information, contact Quest International, Inc. or visit their website. Additional details are available at the FDA recall page.
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