Cepheid Recalls Xpert CT/NG Tests Due to Temperature Drift Errors
Cepheid is recalling specific batches of Xpert CT/NG tests due to reports of higher-than-expected temperature drift errors and an occasional probability of false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of false negative results, which is a risk-of-harm product where specific injury or illness has not yet been reported, fitting the High severity criteria.
Plain-English summary
Cepheid has initiated a recall for specific batches of the Xpert CT/NG qualitative in vitro real-time PCR test. The affected products include Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156, and Catalog GXCT/NG-10 Batch 1000056157. The recall covers 3,586 kits (49,400 units) with lot numbers 25718, 25719, 25725, and 25727.
The recall was issued because Cepheid received reports that customers experienced a higher number of temperature drift errors than typically expected when using the test with its intended specimen types. An investigation into the issue also revealed an occasional probability of false negative results, which the company notes remains consistent with the package insert claims.
The affected products were distributed worldwide, including in the USA, Puerto Rico, and Haiti. Users of these specific test kits should stop using them and contact Cepheid for further instructions.
The recalled product
- Product
- Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
- Manufacturer
- Cepheid
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot numbers: 25718
- 25719
- 25725
- and 25727.
Distribution
Distributed in 1 state:
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