FDA-Device2018-02-21Class II
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.
Cepheid
Hazard
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
Sold states
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Affected count
3,586 kits (49,400 units)
Manufactured in
904 E Caribbean Dr, Sunnyvale, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0592-2018Don't want to check this manually?
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