Device 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.
Z-0592-2018
Product summary
- Firm
- Cepheid
- Event
- Event 78910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,586 kits (49,400 units)
- Official record key
device-enforcement:Z-0592-2018
Official wording
Reason: 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.
Code information: Lot numbers: 25718, 25719, 25725, and 25727.
Distribution pattern: Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Derived failure modes
-
Unknown
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.