Cepheid recalls Xpert MTB/RIF model GXMTB/RIF-US-10 due to instability in product testing. Affected units may not meet stability criteria. Contact for remedy details.
Product testing did not meet expected stability criteria.
Cepheid is recalling Xpert MTB/RIF devices with model number GXMTB/RIF-US-10 because testing showed they don't meet expected stability standards. This could mean the devices might not function properly over time, but the recall doesn: t mention specific safety risks like injury or fire.
The product testing did not meet expected stability criteria, meaning the device might not perform reliably over time. This could lead to inaccurate test results if the device is used beyond its intended stability period. However, the recall does not specify any immediate safety hazards like injury or fire.
Users of the Xpert MTB/RIF device with model number GXMTB/RIF-US-10 are affected. Healthcare providers and labs that use this device for tuberculosis and rifampin testing are most at risk.
Check for the model number GXMTB/RIF-US-10 on the device. The device also has a unique identifier (UDI-DI: 07332940000912) and batch number 1000812229 with lot number 41302. The expiration date is February 2, 2025.
Look for the model number GXMTB/RIF-US-10 on the device label.
The product testing did not meet expected stability criteria, meaning the device may not function reliably over time.
The recall does not specify a remedy, so contact Cepheid for further instructions.
The recall does not mention any safety hazards like injury or fire.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0724-2026 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0724-2026 from Cepheid. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
