Cepheid recalled 9,880 units of Xpert MTB/RIF GXMTB/RIF-US-10 after testing failed to meet stability criteria. The devices were distributed nationwide in the United States and Puerto Rico. Health care providers and patients should stop using the device immediately and follow the recall instructions.
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 Xpert MTB/RIF GXMTB/RIF-US-10 is a Cepheid molecular diagnostic instrument used for rapid tuberculosis testing in clinical settings.
The hazard arises from stability criteria not being met during testing, which may affect device performance.
This recall is not described as part of a broader industry pattern in the provided notice.
The notification affects healthcare facilities using the GXMTB/RIF-US-10, potentially impacting test stability and reliability until resolved.
Recall notices and instructions are published by Cepheid and the FDA enforcement database linked in the recall notice.
Refunds or replacements are typically processed within 4-8 weeks, subject to Cepheid procedures.
Keep all recall communications, serial numbers, shipment records, and correspondence with Cepheid.
Model: GXMTB/RIF-US-10 UDI-DI: 07332940000912 Batch: 1000812229 Lot: 41302 Expiration Date: 2025-02-02 Quantity: 9,880 units Distribution: US nationwide and Puerto Rico Recall Date: 2025-11-05 Status: ACTIVE Manufacturer: Cepheid
No injuries or incidents have been reported.
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