Cepheid recalled 9,880 units of the Xpert MTB/RIF testing device on November 5, 2025. Product testing failed to meet expected stability criteria, leading to potential inaccuracies. Healthcare providers and patients must stop using the device immediately.
Product testing did not meet expected stability criteria.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cepheid or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Xpert MTB/RIF with Model Number GXMTB/RIF-US-10. It was distributed nationwide in the U.S. and Puerto Rico. The device has a UDI-DI of 07332940000912, batch number 1000812229, lot number 41302, and an expiration date of February 2, 2025.
The device failed stability testing, which raises concerns about its reliability in diagnosing tuberculosis. This failure could lead to misdiagnosis or delayed treatment for patients.
There are no reported injuries or incidents related to this recall. The stability issue is a preventative measure to ensure patient safety.
Patients and healthcare providers should stop using the Xpert MTB/RIF device immediately. Contact Cepheid or your healthcare provider for further instructions and follow the recall instructions provided.
For more information, contact Cepheid at their customer service number or visit their website. The recall notification was sent via letter to affected users.
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